Heart valve sealing devices and delivery devices therefor

ABSTRACT

An exemplary valve repair device for repairing a native valve of a patient has a paddle frame, an inner paddle, and an outer paddle. The outer paddle is connected to the inner paddle. The inner and outer paddles are connected to the paddle frame at a connection between the inner paddle and the outer paddle. A portion of the inner paddle is moveable away from a portion of the outer paddle to open the inner and outer paddles.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is related to and claims priority to PCTApplication Serial No. PCT/US18/28189, filed on Apr. 18, 2018, titledHEART VALVE SEALING DEVICES AND DELIVERY DEVICES THEREFOR, which claimsbenefit of U.S. Provisional Application Ser. No. 62/486,835, filed onApr. 18, 2017, titled HEART VALVE SEALING DEVICES AND DELIVERY DEVICESTHEREFOR, 62/504,389, filed on May 10, 2017, titled MITRAL VALVE SPACERDEVICE, 62/555,240, filed Sep. 7, 2017, titled PROSTHETIC SPACER DEVICEFOR HEART VALVE and 62/571,552 filed on Oct. 12, 2017, titled MITRALVALVE SPACER DEVICE, the disclosures of which are all incorporatedherein by reference in their entireties.

TECHNICAL FIELD

The present application relates generally to prosthetic devices andrelated methods for helping to seal native heart valves and prevent orreduce regurgitation therethrough, as well as devices and relatedmethods for implanting such prosthetic devices.

BACKGROUND OF THE INVENTION

The native heart valves (i.e., the aortic, pulmonary, tricuspid, andmitral valves) serve critical functions in assuring the forward flow ofan adequate supply of blood through the cardiovascular system. Theseheart valves can be damaged, and thus rendered less effective, bycongenital malformations, inflammatory processes, infectious conditions,or disease. Such damage to the valves can result in seriouscardiovascular compromise or death. For many years the definitivetreatment for such damaged valves was surgical repair or replacement ofthe valve during open heart surgery. However, open heart surgeries arehighly invasive and are prone to many complications. Therefore, elderlyand frail patients with defective heart valves often went untreated.More recently, transvascular techniques have been developed forintroducing and implanting prosthetic devices in a manner that is muchless invasive than open heart surgery. One particular transvasculartechnique that is used for accessing the native mitral and aortic valvesis the trans-septal technique. The trans septal technique comprisesinserting a catheter into the right femoral vein, up the inferior venacava and into the right atrium. The septum is then punctured and thecatheter passed into the left atrium.

A healthy heart has a generally conical shape that tapers to a lowerapex. The heart is four-chambered and comprises the left atrium, rightatrium, left ventricle, and right ventricle. The left and right sides ofthe heart are separated by a wall generally referred to as the septum.The native mitral valve of the human heart connects the left atrium tothe left ventricle. The mitral valve has a very different anatomy thanother native heart valves. The mitral valve includes an annulus portion,which is an annular portion of the native valve tissue surrounding themitral valve orifice, and a pair of cusps, or leaflets, extendingdownward from the annulus into the left ventricle. The mitral valveannulus can form a “D”-shaped, oval, or otherwise out-of-roundcross-sectional shape having major and minor axes. The anterior leafletcan be larger than the posterior leaflet, forming a generally “C”-shapedboundary between the abutting sides of the leaflets when they are closedtogether.

When operating properly, the anterior leaflet and the posterior leafletfunction together as a one-way valve to allow blood to flow only fromthe left atrium to the left ventricle. The left atrium receivesoxygenated blood from the pulmonary veins. When the muscles of the leftatrium contract and the left ventricle dilates (also referred to as“ventricular diastole” or “diastole”), the oxygenated blood that iscollected in the left atrium flows into the left ventricle. When themuscles of the left atrium relax and the muscles of the left ventriclecontract (also referred to as “ventricular systole” or “systole”), theincreased blood pressure in the left ventricle urges the sides of thetwo leaflets together, thereby closing the one-way mitral valve so thatblood cannot flow back to the left atrium and is instead expelled out ofthe left ventricle through the aortic valve. To prevent the two leafletsfrom prolapsing under pressure and folding back through the mitralannulus toward the left atrium, a plurality of fibrous cords calledchordae tendineae tether the leaflets to papillary muscles in the leftventricle.

Mitral regurgitation occurs when the native mitral valve fails to closeproperly and blood flows into the left atrium from the left ventricleduring the systolic phase of heart contraction. Mitral regurgitation isthe most common form of valvular heart disease. Mitral regurgitation hasdifferent causes, such as leaflet prolapse, dysfunctional papillarymuscles and/or stretching of the mitral valve annulus resulting fromdilation of the left ventricle. Mitral regurgitation at a centralportion of the leaflets can be referred to as central jet mitralregurgitation and mitral regurgitation nearer to one commissure (i.e.,the location where the leaflets meet) of the leaflets can be referred toas eccentric jet mitral regurgitation. Central jet regurgitation occurswhen the edges of the leaflets do not meet in the middle and thus thevalve does not close and regurgitation is present.

Some prior techniques for treating mitral regurgitation in patientsinclude surgically stitching the edges of the native mitral valveleaflets directly to one another. A catheter delivered clip has beenused to attempt to clip the sides of the leaflets together at the endportions of the leaflets, similar to the surgical stitching method.However, this clip has shortcomings, since it can only be used to clipthe middle of the leaflets where they overlap by about 2 mm or more.Alternately, attempts have been made to use multiple clips on thecommissures of the mitral valve, where there may be more overlap of theleaflets. This technique results in a longer operation time and alsojoins the patient's leaflets at the sides, restricting blood flow.Additionally, both the surgical and clip treatments are thought tocreate stress on patient leaflets.

Despite these prior techniques, there is a continuing need for improveddevices and methods for treating mitral valve regurgitation.

SUMMARY

An exemplary implantable prosthetic device can have a coaption elementand at least one anchor. The coaption element is configured to bepositioned within the native heart valve orifice to help fill a spacewhere the native valve is regurgitant and form a more effective seal.The coaption element can have a structure that is impervious to bloodand that allows the native leaflets to close around the coaption elementduring ventricular systole to block blood from flowing from the left orright ventricle back into the left or right atrium, respectively. Thecoaption element can be connected to leaflets of the native valve by theanchor.

An exemplary valve repair device for repairing a native valve of apatient can have a paddle frame, an inner paddle, and an outer paddle.The outer paddle is connected to the inner paddle. The inner and outerpaddles are connected to the paddle frame at a connection between theinner paddle and the outer paddle. A portion of the inner paddle ismoveable away from a portion of the outer paddle to open the inner andouter paddles.

A further understanding of the nature and advantages of the presentinvention are set forth in the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify various aspects of embodiments of the presentdisclosure, a more particular description of the certain embodimentswill be made by reference to various aspects of the appended drawings.It is appreciated that these drawings depict only typical embodiments ofthe present disclosure and are therefore not to be considered limitingof the scope of the disclosure. Moreover, while the figures can be drawnto scale for some embodiments, the figures are not necessarily drawn toscale for all embodiments. Embodiments and other features and advantagesof the present disclosure will be described and explained withadditional specificity and detail through the use of the accompanyingdrawings in which:

FIG. 1 illustrates a cutaway view of the human heart in a diastolicphase;

FIG. 2 illustrates a cutaway view of the human heart in a systolicphase;

FIG. 2A is another cutaway view of the human heart in a systolic phase;

FIG. 2B is the cutaway view of FIG. 2A annotated to illustrate a naturalshape of mitral valve leaflets in the systolic phase;

FIG. 3 illustrates a cutaway view of the human heart in a diastolicphase, in which the chordae tendineae are shown attaching the leafletsof the mitral and tricuspid valves to ventricle walls;

FIG. 4 illustrates a healthy mitral valve with the leaflets closed asviewed from an atrial side of the mitral valve;

FIG. 5 illustrates a dysfunctional mitral valve with a visible gapbetween the leaflets as viewed from an atrial side of the mitral valve;

FIG. 6 illustrates a mitral valve having a wide gap between theposterior leaflet and the anterior leaflet;

FIG. 6A illustrates a coaption element in the gap of the mitral valve asviewed from an atrial side of the mitral valve;

FIG. 6B illustrates a valve repair device attached to mitral valveleaflets with the coaption element in the gap of the mitral valve asviewed from a ventricular side of the mitral valve;

FIG. 6C is a perspective view of a valve repair device attached tomitral valve leaflets with the coaption element in the gap of the mitralvalve shown from a ventricular side of the mitral valve;

FIG. 6D is a schematic view illustrating a path of mitral valve leafletsalong each side of a coaption element of mitral valve repair device;

FIG. 6E is a top schematic view illustrating a path of mitral valveleaflets around a coaption element of a mitral valve repair device;

FIG. 7 illustrates a tricuspid valve viewed from an atrial side of thetricuspid valve;

FIGS. 8-14 show an exemplary embodiment of an implantable prostheticdevice, in various stages of deployment;

FIG. 11A shows an exemplary embodiment of an implantable prostheticdevice that is similar to the device illustrated by FIG. 11, but wherethe paddles are independently controllable;

FIGS. 15-20 show the implantable prosthetic device of FIGS. 8-14 beingdelivered and implanted within the native mitral valve;

FIG. 21 shows an exemplary embodiment of an implantable prostheticdevice;

FIG. 22 shows an exemplary embodiment of an implantable prostheticdevice;

FIGS. 23-25 show an exemplary embodiment of an implantable prostheticdevice;

FIGS. 26 and 27 show an exemplary embodiment of a barbed clasp for usein an implantable prosthetic device;

FIGS. 28-32 show an exemplary embodiment of an implantable prostheticdevice;

FIGS. 32A and 32B are perspective views of a cap and a coaption elementinsert of the implantable prosthetic device of FIGS. 28-32 in sealed andspaced apart positions, respectively;

FIG. 33 shows a barbed clasp for use in an implantable prostheticdevice;

FIG. 34 shows a portion of mitral valve tissue grasped by a barbedclasp;

FIGS. 35-46 show an exemplary embodiment of an implantable prostheticdevice being delivered and implanted within the native mitral valve;

FIG. 47 shows a side view of an exemplary implantable prosthetic deviceaccording without barbed clasps in a closed position;

FIG. 48 shows a side view of an exemplary implantable prosthetic deviceaccording with barbed clasps in a closed position;

FIG. 49 shows a side view of an exemplary implantable prosthetic deviceaccording without barbed clasps in a partially-open position;

FIG. 50 shows a side view of an exemplary implantable prosthetic devicein a partially-open position with barbed clasps in an open position;

FIG. 51 shows a side view of an exemplary implantable prosthetic devicein a partially-open position with barbed clasps in a closed position;

FIG. 52 shows a side view of an exemplary implantable prosthetic devicewithout barbed clasps in a half-open position;

FIG. 53 shows a side view of an exemplary implantable prosthetic devicein a half-open position with barbed clasps in a closed position;

FIG. 54 shows a side view of an exemplary implantable prosthetic devicein a half-open position with barbed clasps in an open position;

FIG. 55 shows a side view of an exemplary implantable prosthetic devicewithout barbed clasps in a three-quarters-open position;

FIG. 56 shows a side view of an exemplary implantable prosthetic devicein a three-quarters-open position with barbed clasps in a closedposition;

FIG. 57 shows a side view of an exemplary implantable prosthetic devicein a three-quarters-open position with barbed clasps in an openposition;

FIG. 58 shows a side view of an exemplary implantable prosthetic devicewithout barbed clasps near a full bailout position;

FIG. 59 shows a side view of an exemplary implantable prosthetic devicewithout barbed clasps in a full bailout position;

FIG. 60 shows a side view of an exemplary implantable in a full bailoutposition with barbed clasps in a closed position;

FIG. 61 shows a side view of an exemplary implantable in a full bailoutposition with barbed clasps in an open position;

FIGS. 62A-62B illustrate the movement of the paddles of an exemplaryembodiment of an implantable prosthetic device;

FIGS. 63A-63C illustrate the movement of the paddles of an exemplaryembodiment of an implantable prosthetic device;

FIGS. 64A-64C illustrate the movement of the paddles of an exemplaryembodiment of an implantable prosthetic device;

FIG. 65 shows a perspective view of an exemplary implantable prostheticdevice in a closed position;

FIG. 66 shows a perspective view of the implantable prosthetic device ofFIG. 65;

FIG. 67 shows a front view of the implantable prosthetic device of FIG.65;

FIG. 68 shows a front view of the implantable prosthetic device of FIG.65 with additional components;

FIG. 69 shows a side view of the implantable prosthetic device of FIG.65;

FIG. 70 shows a top view of the implantable prosthetic device of FIG.65;

FIG. 71 shows a top view of the implantable prosthetic device of FIG. 65with a collar component;

FIG. 72 shows a bottom view of the implantable prosthetic device of FIG.65;

FIG. 73 shows a bottom view of the implantable prosthetic device of FIG.65 with a cap component;

FIG. 74 shows a sectioned perspective view of the implantable prostheticdevice of FIG. 65 sectioned by cross-section plane 75;

FIG. 75 shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 74;

FIG. 76 shows a sectioned perspective view of the implantable prostheticdevice of FIG. 65 sectioned by cross-section plane 77;

FIG. 77 shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 76;

FIG. 78 shows a sectioned perspective view of the implantable prostheticdevice of FIG. 65 sectioned by cross-section plane 77;

FIG. 79 shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 78;

FIG. 80 shows a sectioned perspective view of the implantable prostheticdevice of FIG. 65 sectioned by cross-section plane 81;

FIG. 81 shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 80;

FIG. 82 shows a sectioned perspective view of the implantable prostheticdevice of FIG. 65 sectioned by cross-section plane 83;

FIG. 83 shows a top cross-section view of the exemplary prostheticdevice illustrated by FIG. 82;

FIG. 84 shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 85 shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 86 shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 87 shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 88 shows an exemplary embodiment of an implantable prostheticdevice with integral barbs;

FIG. 89 shows a perspective view of a coapting portion and paddleportions of the implantable prosthetic device illustrated by FIG. 65;

FIG. 90 shows a perspective view of a coapting portion and paddleportions of the implantable prosthetic device illustrated by FIG. 65;

FIG. 91 shows a front view of a coapting portion and paddle portions ofthe implantable prosthetic device illustrated by FIG. 65;

FIG. 92 shows a side view of a coapting portion and paddle portions ofthe implantable prosthetic device illustrated by FIG. 65;

FIG. 93 shows a top view of a coapting portion and paddle portions ofthe implantable prosthetic device illustrated by FIG. 65;

FIG. 94 shows a bottom view of a coapting portion and portions of theimplantable prosthetic device illustrated by FIG. 65;

FIG. 95 shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65 with the section taken across plane 96;

FIG. 96 shows a cross-section view of the coapting portion and paddleportions of FIG. 95;

FIG. 97 shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65 with the section taken across plane 98;

FIG. 98 shows a cross-section view of the coapting portion and paddleportions of FIG. 97;

FIG. 99 shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65 with the section taken across plane 100;

FIG. 100 shows a cross-section view of the coapting portion and paddleportions of FIG. 99;

FIG. 101 shows a sectioned perspective view of a coapting portion andpaddle portions of the implantable prosthetic device illustrated by FIG.65 with the section taken across plane 102;

FIG. 102 shows a cross-section view of the coapting portion and paddleportions of FIG. 101;

FIG. 103 shows an exemplary embodiment of an implantable prostheticdevice;

FIG. 104 shows an exemplary embodiment of an implantable prostheticdevice;

FIG. 105 shows an exemplary embodiment of an implantable prostheticdevice;

FIG. 106 shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106A shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106B shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106C shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106D shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106E shows a side view of an exemplary embodiment of an expandablecoaption element in an unexpanded condition;

FIG. 106F shows an exemplary embodiment of an expandable coaptionelement;

FIG. 106G shows an exemplary embodiment of an expandable coaptionelement;

FIG. 106H shows an exemplary embodiment of an expandable coaptionelement;

FIG. 106I shows an exemplary embodiment of an expandable coaptionelement;

FIG. 107 shows an end view of the expandable coaption element of FIG.106;

FIG. 108 shows the expandable coaption element of FIG. 106 in anexpanded condition;

FIG. 108A shows the expandable coaption element of FIG. 106A in anexpanded condition;

FIG. 108B shows the expandable coaption element of FIG. 106B in anexpanded condition;

FIG. 108C shows the expandable coaption element of FIG. 106C in anexpanded condition;

FIG. 108D shows the expandable coaption element of FIG. 106D in anexpanded condition;

FIG. 108E shows the expandable coaption element of FIG. 106E in anexpanded condition;

FIG. 109 shows an end view of the coaption element of FIG. 108;

FIG. 110 shows a side view of an exemplary embodiment of an implantableprosthetic device;

FIG. 111 shows an end view of a coaption element of the exemplaryprosthetic device of FIG. 110, taken along lines 111.

FIGS. 112-114 show perspective views of an exemplary embodiment of apaddle frame for the implantable prosthetic device of FIG. 65;

FIG. 115 shows a front view of the paddle frame of FIGS. 112-114;

FIG. 116 shows a top view of the paddle frame of FIGS. 112-114;

FIG. 117 shows a side view of the paddle frame of FIGS. 112-114;

FIG. 118 shows a bottom view of the paddle frame of FIGS. 112-114;

FIG. 119 shows a front view of the paddle frame of FIGS. 112-114;

FIG. 120 shows a front view of the paddle frame of FIGS. 112-114 in acompressed condition inside a delivery device;

FIG. 121 shows a side view of an exemplary embodiment of an implantableprosthetic device in a closed condition;

FIG. 122 shows a front view of a paddle frame of the exemplaryprosthetic device of FIG. 121;

FIG. 123 shows a side view of the implantable prosthetic device of FIG.121 in a closed condition;

FIG. 124 shows a front view of the paddle frame of the open prostheticdevice of FIG. 123;

FIG. 125 shows a side view of an exemplary embodiment of an implantableprosthetic device in a closed condition;

FIG. 126 shows a front view of a paddle frame of the exemplaryprosthetic device of FIG. 125;

FIG. 127 shows a side view of the implantable prosthetic device of FIG.125 in a closed condition;

FIG. 128 shows a front view of the paddle frame of the open prostheticdevice of FIG. 127;

FIG. 129 shows an exemplary embodiment of an implantable prostheticdevice;

FIGS. 130-131 show an exemplary embodiment of an implantable prostheticdevice;

FIG. 132 shows an exemplary embodiment of an implantable prostheticdevice;

FIGS. 133-134 show an exemplary embodiment of an implantable prostheticdevice;

FIGS. 135-136 show an exemplary embodiment of an implantable prostheticdevice;

FIG. 137 shows an exemplary embodiment of an implantable prostheticdevice;

FIGS. 138-143 show use of an exemplary embodiment of an implantableprosthetic device;

FIG. 144 shows an exemplary embodiment of a delivery assembly includinga delivery device and an exemplary prosthetic device;

FIG. 145 shows a perspective view of an exemplary embodiment of animplantable prosthetic device releasably coupled to a delivery device;

FIG. 146 shows the embodiment of FIG. 145 with the inplantableprosthetic device released from to the delivery device;

FIG. 147 shows a cross-sectional view of the coupler of FIG. 145;

FIG. 148 shows a perspective view of the delivery assembly of FIG. 144with the prosthetic device shown in partial cross-section and somecomponents of the delivery apparatus shown schematically;

FIG. 149 shows a plan view of a shaft of the delivery device of FIG.144;

FIG. 150 shows a side elevation view of a proximal end portion of thedelivery device of FIG. 144;

FIG. 151 shows a cross-sectional view of the proximal end portion of thedelivery device of FIG. 144, taken along the line 150-150 shown in FIG.150;

FIG. 152 shows an exploded view of the proximal end portion of thedelivery device of FIG. 144;

FIGS. 153-160 show an exemplary procedure used to repair a native mitralvalve of a heart, which is partially shown;

FIG. 161 shows an exemplary embodiment of a handle for the deliveryapparatus of FIG. 144;

FIG. 162 is an exploded view of the handle of FIG. 161;

FIG. 163 shows an exemplary embodiment of a coupler and a proximalcollar for the delivery assembly of FIG. 144, showing the couplerreleasably coupled to the proximal collar;

FIG. 164 shows a perspective view of the coupler and proximal collar ofFIG. 163, showing the coupler released from the proximal collar;

FIG. 165 shows other exemplary embodiments of a cap, actuation shaft,and release wire for the delivery assembly of FIG. 144, showing the capreleasably coupled to the actuation shaft by the release wire.

FIG. 166 shows a perspective view of the cap, actuation shaft, and therelease wire of FIG. 163, showing the cap released from the actuationshaft and the release wire;

FIG. 167 shows other exemplary embodiments of a coupler, a proximalcollar, a cap, and an actuation shaft of the delivery assembly of FIG.144;

FIG. 168 shows a perspective view of the coupler and proximal collar ofFIG. 167;

FIG. 169 shows an exemplary embodiment of a clasp control member of thedelivery apparatus of FIG. 144;

FIG. 170 shows a detail view of the clasp control member of FIG. 169,taken from the perspective 170 shown in FIG. 169;

FIG. 171 shows an exemplary embodiment of a guide rail for the claspcontrol member of FIG. 169;

FIG. 172 shows an exemplary embodiment of a shaft of the delivery deviceof FIG. 144;

FIGS. 173-176 show an exemplary embodiment of an implantable prostheticdevice and delivery device for releasing and recapturing the prostheticdevice;

FIGS. 174A and 175A show an exemplary embodiment of an implantableprosthetic device and delivery device for releasing and recapturing theprosthetic device;

FIGS. 177-178 show an exemplary embodiment of a coupler for an exemplaryimplantable prosthetic device;

FIGS. 179-181 show an exemplary embodiment of a coupler for an exemplaryimplantable prosthetic device;

FIGS. 182-183 show an exemplary embodiment of a coupler for an exemplaryimplantable prosthetic device;

FIGS. 184-185 show an exemplary embodiment of a coupler for an exemplaryimplantable prosthetic device;

FIG. 186 shows an exemplary embodiment of an actuation shaft for anexemplary prosthetic device;

FIG. 187 shows an actuation mechanism for an exemplary prostheticdevice;

FIG. 188 shows an actuation mechanism for an exemplary prostheticdevice;

FIG. 188A shows an actuation mechanism for an exemplary prostheticdevice;

FIG. 189 shows an actuation mechanism for an exemplary prostheticdevice;

FIG. 190 shows an actuation mechanism for an exemplary prostheticdevice;

FIG. 191 is a perspective view of a blank used to make a paddle frame;

FIG. 192 is a perspective view of the blank of FIG. 191 bent to make apaddle frame;

FIG. 193 is a perspective view of a shape set paddle frame attached to acap of a valve repair device; and

FIG. 194 is a perspective view of the paddle frame of FIG. 193 flexedand attached to inner and outer paddles at a closed position.

DETAILED DESCRIPTION

The following description refers to the accompanying drawings, whichillustrate specific embodiments of the present disclosure. Otherembodiments having different structures and operation do not depart fromthe scope of the present disclosure.

Exemplary embodiments of the present disclosure are directed to devicesand methods for repairing a defective heart valve. It should be notedthat various embodiments of native valve reparation devices and systemsfor delivery are disclosed herein, and any combination of these optionscan be made unless specifically excluded. In other words, individualcomponents of the disclosed devices and systems can be combined unlessmutually exclusive or otherwise physically impossible.

As described herein, when one or more components are described as beingconnected, joined, affixed, coupled, attached, or otherwiseinterconnected, such interconnection may be direct as between thecomponents or may be indirect such as through the use of one or moreintermediary components. Also as described herein, reference to a“member,” “component,” or “portion” shall not be limited to a singlestructural member, component, or element but can include an assembly ofcomponents, members, or elements. Also as described herein, the terms“substantially” and “about” are defined as at least close to (andincludes) a given value or state (preferably within 10% of, morepreferably within 1% of, and most preferably within 0.1% of).

FIGS. 1 and 2 are cutaway views of the human heart H in diastolic andsystolic phases, respectively. The right ventricle RV and left ventricleLV are separated from the right atrium RA and left atrium LA,respectively, by the tricuspid valve TV and mitral valve MV; i.e., theatrioventricular valves. Additionally, the aortic valve AV separates theleft ventricle LV from the ascending aorta AA, and the pulmonary valvePV separates the right ventricle from the pulmonary artery PA. Each ofthese valves has flexible leaflets (e.g., leaflets 20, 22 shown in FIGS.4 and 5) extending inward across the respective orifices that cometogether or “coapt” in the flowstream to form the one-way,fluid-occluding surfaces. The native valve repair systems of the presentapplication are described primarily with respect to the mitral valve MV.Therefore, anatomical structures of the left atrium LA and leftventricle LV will be explained in greater detail. It should beunderstood that the devices described herein may also be used inrepairing other native valves, e.g., the devices can be used inrepairing the tricuspid valve TV, the aortic valve AV, and the pulmonaryvalve PV.

The left atrium LA receives oxygenated blood from the lungs. During thediastolic phase, or diastole, seen in FIG. 1, the blood that waspreviously collected in the left atrium LA (during the systolic phase)moves through the mitral valve MV and into the left ventricle LV byexpansion of the left ventricle LV. In the systolic phase, or systole,seen in FIG. 2, the left ventricle LV contracts to force the bloodthrough the aortic valve AV and ascending aorta AA into the body. Duringsystole, the leaflets of the mitral valve MV close to prevent the bloodfrom regurgitating from the left ventricle LV and back into the leftatrium LA, and blood is collected in the left atrium from the pulmonaryvein. In one exemplary embodiment, the devices described by the presentapplication are used to repair the function of a defective mitral valveMV. That is, the devices are configured to help close the leaflets ofthe mitral valve to prevent blood from regurgitating from the leftventricle LV and back into the left atrium LA. Unlike the prior art thatdescribes using sutures or clips often require multiple sutures or clipsand additional supports to treat large regurgitant orifices, the devicesdescribed in the present application are designed to easily grasp andsecure the native leaflets around a coaption element that acts as afiller in the regurgitant orifice.

Referring now to FIGS. 1-7, the mitral valve MV includes two leaflets,the anterior leaflet 20 and the posterior leaflet 22. The mitral valveMV also includes an annulus 24, which is a variably dense fibrous ringof tissues that encircles the leaflets 20, 22. Referring to FIG. 3, themitral valve MV is anchored to the wall of the left ventricle LV bychordae tendineae 10. The chordae tendineae 10 are cord-like tendonsthat connect the papillary muscles 12 (i.e., the muscles located at thebase of the chordae tendineae and within the walls of the leftventricle) to the leaflets 20, 22 of the mitral valve MV. The papillarymuscles 12 serve to limit the movements of the mitral valve MV andprevent the mitral valve from being reverted. The mitral valve MV opensand closes in response to pressure changes in the left atrium LA and theleft ventricle LV. The papillary muscles do not open or close the mitralvalve MV. Rather, the papillary muscles brace the mitral valve MVagainst the high pressure needed to circulate blood throughout the body.Together the papillary muscles and the chordae tendineae are known asthe subvalvular apparatus, which functions to keep the mitral valve MVfrom prolapsing into the left atrium LA when the mitral valve closes.

Various disease processes can impair proper function of one or more ofthe native valves of the heart H. These disease processes includedegenerative processes (e.g., Barlow's Disease, fibroelasticdeficiency), inflamatory processes (e.g., Rheumatic Heart Disease), andinfectious processes (e.g., endocarditis). In addition, damage to theleft ventricle LV or the right ventricle RV from prior heart attacks(i.e., myocardial infarction secondary to coronary artery disease) orother heart diseases (e.g., cardiomyopaty) can distort a native valve'sgeometry, which can cause the native valve to dysfunction. However, thevast majority of patients undergoing valve surgery, such as surgery tothe mitral valve MV, suffer from a degenerative disease that causes amalfunction in a leaflet (e.g., leaflets 20, 22) of a native valve(e.g., the mitral valve MV), which results in prolapse andregurgitation.

Generally, a native valve may malfunction in two different ways: (1)valve stenosis; and (2) valve regurgitation. Valve stenosis occurs whena native valve does not open completely and thereby causes anobstruction of blood flow. Typically, valve stenosis results frombuildup of calcified material on the leaflets of a valve, which causesthe leaflets to thicken and impairs the ability of the valve to fullyopen to permit forward blood flow.

The second type of valve malfunction, valve regurgitation, occurs whenthe leaflets of the valve do not close completely thereby causing bloodto leak back into the prior chamber (e.g., causing blood to leak fromthe left ventricle to the left atrium). There are three mechanisms bywhich a native valve becomes regurgitant—or incompetent—which includeCarpentier's type I, type II, and type III malfunctions. A Carpentiertype I malfunction involves the dilation of the annulus such thatnormally functioning leaflets are distracted from each other and fail toform a tight seal (i.e., the leaflets do not coapt properly). Includedin a type I mechanism malfunction are perforations of the leaflets, asare present in endocarditis. A Carpentier's type II malfunction involvesprolapse of one or more leaflets of a native valve above a plane ofcoaption. A Carpentier's type III malfunction involves restriction ofthe motion of one or more leaflets of a native valve such that theleaflets are abnormally constrained below the plane of the annulus.Leaflet restriction can be caused by rheumatic disease (Ma) or dilationof a ventricle (IIIb).

Referring to FIG. 4, when a healthy mitral valve MV is in a closedposition, the anterior leaflet 20 and the posterior leaflet 22 coapt,which prevents blood from leaking from the left ventricle LV to the leftatrium LA. Referring to FIG. 5, regurgitation occurs when the anteriorleaflet 20 and/or the posterior leaflet 22 of the mitral valve MV isdisplaced into the left atrium LA during systole. This failure to coaptcauses a gap 26 between the anterior leaflet 20 and the posteriorleaflet 22, which allows blood to flow back into the left atrium LA fromthe left ventricle LV during systole. As set forth above, there areseveral different ways that a leaflet (e.g. leaflets 20, 22 of mitralvalve MV) may malfunction, which can thereby lead to regurgitation.

Referring to FIG. 6, in certain situations, the mitral valve MV of apatient can have a wide gap 26 between the anterior leaflet 20 and theposterior leaflet 22 when the mitral valve is in a closed position(i.e., during the systolic phase). For example, the gap 26 can have awidth W between about 2.5 mm and about 17.5 mm, such as between about 5mm and about 15 mm, such as between about 7.5 mm and about 12.5 mm, suchas about 10 mm. In some situations, the gap 3002 can have a width Wgreater than 15 mm. In any of the above-mentioned situations, a valverepair device is desired that is capable of engaging the anteriorleaflet 20 and the posterior leaflet 22 to close the gap 26 and preventregurgitation of blood through the mitral valve MV.

Although stenosis or regurgitation can affect any valve, stenosis ispredominantly found to affect either the aortic valve AV or thepulmonary valve PV, and regurgitation is predominantly found to affecteither the mitral valve MV or the tricuspid valve TV. Both valvestenosis and valve regurgitation increase the workload of the heart Hand may lead to very serious conditions if left un-treated; such asendocarditis, congestive heart failure, permanent heart damage, cardiacarrest, and ultimately death. Because the left side of the heart (i.e.,the left atrium LA, the left ventricle LV, the mitral valve MV, and theaortic valve AV) is primarily responsible for circulating the flow ofblood throughout the body, malfunction of the mitral valve MV or theaortic valve AV is particularly problematic and often life threatening.Accordingly, because of the substantially higher pressures on the leftside of the heart, dysfunction of the mitral valve MV or the aorticvalve AV is much more problematic.

Malfunctioning native heart valves may either be repaired or replaced.Repair typically involves the preservation and correction of thepatient's native valve. Replacement typically involves replacing thepatient's native valve with a biological or mechanical substitute.Typically, the aortic valve AV and pulmonary valve PV are more prone tostenosis. Because stenotic damage sustained by the leaflets isirreversible, the most conventional treatments for a stenotic aorticvalve or stenotic pulmonary valve are removal and replacement of thevalve with a surgically implanted heart valve, or displacement of thevalve with a transcatheter heart valve. The mitral valve MV and thetricuspid valve TV are more prone to deformation of leaflets, which, asdescribed above, prevents the mitral valve or tricuspid valve fromclosing properly and allows for regurgitation or back flow of blood fromthe ventricle into the atrium (e.g., a deformed mitral valve MV mayallow for regurgitation or back flow from the left ventricle LV to theleft atrium LA). The regurgitation or back flow of blood from theventricle to the atrium results in valvular insufficiency. Deformationsin the structure or shape of the mitral valve MV or the tricuspid valveTV are often repairable. In addition, regurgitation can occur due to thechordae tendineae 10 becoming dysfunctional (e.g., the chordae tendineaemay stretch or rupture), which allows the anterior leaflet 20 and theposterior leaflet 22 to be reverted such that blood is regurgitated intothe left atrium LA. The problems occurring due to dysfunctional chordaetendineae 10 can be repaired by repairing the chordae tendineae or thestructure of the mitral valve (e.g., by securing the leaflets 20, 22 atthe affected portion of the mitral valve).

The devices and procedures disclosed herein make reference to repairingthe structure of a mitral valve. However, it should be understood thatthe devices and concepts provided herein can be used to repair anynative valve, as well as any component of a native valve. Referring nowto FIG. 7, any of the devices and concepts provided herein can be usedto repair the tricuspid valve TV. For example, any of the devices andconcepts provided herein can be used between any two of the anteriorleaflet 30, septal leaflet 32, and posterior leaflet 34 to preventregurgitation of blood from the right ventricle into the right atrium.In addition, any of the devices and concepts provided herein can be usedon all three of the leaflets 30, 32, 34 together to preventregurgitation of blood from the right ventricle to the right atrium.That is, the valve repair devices provided herein can be centrallylocated between the three leaflets 30, 32, 34.

An exemplary implantable prosthetic device has a coaption element and atleast one anchor. The coaption element is configured to be positionedwithin the native heart valve orifice to help fill the space and form amore effective seal, thereby reducing or preventing regurgitationdescribed above. The coaption element can have a structure that isimpervious to blood and that allows the native leaflets to close aroundthe coaption element during ventricular systole to block blood fromflowing from the left or right ventricle back into the left or rightatrium, respectively. The prosthetic device can be configured to sealagainst two or three native valve leaflets; that is, the device may beused in the native mitral (bicuspid) and tricuspid valves. The coaptionelement is sometimes referred to herein as a spacer because the coaptionelement can fill a space between improperly functioning native mitral ortricuspid leaflets that do not close completely.

The coaption element can have various shapes. In some embodiments, thecoaption element can have an elongated cylindrical shape having a roundcross-sectional shape. In other embodiments, the coaption element canhave an oval cross-sectional shape, a crescent cross-sectional shape, orvarious other non-cylindrical shapes. The coaption element can have anatrial portion positioned in or adjacent to the left atrium, aventricular or lower portion positioned in or adjacent to the leftventricle, and a side surface that extends between the native mitralleaflets. In embodiments configured for use in the tricuspid valve, theatrial or upper portion is positioned in or adjacent to the rightatrium, and the ventricular or lower portion is positioned in oradjacent to the right ventricle, and the side surface that extendsbetween the native tricuspid leaflets.

The anchor can be configured to secure the device to one or both of thenative mitral leaflets such that the coaption element is positionedbetween the two native leaflets. In embodiments configured for use inthe tricuspid valve, the anchor is configured to secure the device toone, two, or three of the tricuspid leaflets such that the coaptionelement is positioned between the three native leaflets. In someembodiments, the anchor can attach to the coaption element at a locationadjacent the ventricular portion of the coaption element. In someembodiments, the anchor can attach to a shaft or actuation wire, towhich the coaption element is also attached. In some embodiments, theanchor and the coaption element can be positioned independently withrespect to each other by separately moving each of the anchor and thecoaption element along the longitudinal axis of the shaft or actuationwire. In some embodiments, the anchor and the coaption element can bepositioned simultaneously by moving the anchor and the coaption elementtogether along the longitudinal axis of the shaft or actuation wire. Theanchor can be configured to be positioned behind a native leaflet whenimplanted such that the leaflet is grasped by the anchor.

The prosthetic device can be configured to be implanted via a deliverysheath. The coaption element and the anchor can be compressible to aradially compressed state and can be self-expandable to a radiallyexpanded state when compressive pressure is released. The device can beconfigured for the anchor to be expanded radially away from thestill-compressed coaption element initially in order to create a gapbetween the coaption element and the anchor. A native leaflet can thenbe positioned in the gap. The coaption element can be expanded radially,closing the gap between the coaption element and the anchor andcapturing the leaflet between the coaption element and the anchor. Insome embodiments, the anchor and coaption element are optionallyconfigured to self-expand. The implantation methods for variousembodiments can be different and are more fully discussed below withrespect to each embodiment. Additional information regarding these andother delivery methods can be found in U.S. Pat. No. 8,449,599 and U.S.Patent Application Publication Nos. 2014/0222136, and 2014/0067052,2016/0331523 each of which is incorporated herein by reference in itsentirety.

The disclosed prosthetic devices can be configured such that the anchoris connected to a leaflet, taking advantage of the tension from nativechordae tendineae to resist high systolic pressure urging the devicetoward the left atrium. During diastole, the devices can rely on thecompressive and retention forces exerted on the leaflet that is graspedby the anchor.

Referring now to FIGS. 8-14, a schematically illustrated implantableprosthetic device 100 is shown in various stages of deployment. Thedevice 100 can include any other features for an implantable prostheticdevice discussed in the present application, and the device 100 can bepositioned to engage valve tissue 20, 22 as part of any suitable valverepair system (e.g., any valve repair system disclosed in the presentapplication).

The device 100 is deployed from a delivery sheath 102 and includes acoaption portion 104 and an anchor portion 106. The coaption portion 104of the device 100 includes a coaption element 110 that is adapted to beimplanted between the leaflets of the native mitral valve and isslidably attached to an actuation wire or shaft 112. The anchor portion106 is actuatable between open and closed conditions and can take a widevariety of forms, such as, for example, paddles, gripping elements, orthe like. Actuation of the actuation wire 112 opens and closes theanchor portion 106 of the device 100 to grasp the mitral valve leafletsduring implantation. The actuation wire or shaft 112 may take a widevariety of different forms. For example, the actuation wire or shaft maybe threaded such that rotation of the actuation wire or shaft moves theanchor portion 106 relative to the coaption portion 104. Or, theactuation wire or shaft may be unthreaded, such that pushing or pullingthe actuation wire or shaft 112 moves the anchor portion 106 relative tothe coaption portion 104.

The anchor portion 106 of the device 100 includes outer paddles 120 andinner paddles 122 that are connected between a cap 114 and the coaptionelement 110 by portions 124, 126, 128. The portions 124, 126, 128 may bejointed and/or flexible to move between all of the positions describedbelow. The interconnection of the outer paddles 120, the inner paddles122, the coaption element 110, and the cap 114 by the portions 124, 126,and 128 can constrain the device to the positions and movementsillustrated herein.

The actuation wire 112 extends through the delivery sheath and thecoaption element 110 to the cap 114 at the distal connection of theanchor portion 106. Extending and retracting the actuation wire 112increases and decreases the spacing between the coaption element 110 andthe cap 114, respectively. A collar removably attaches the coaptionelement 110 to the delivery sheath 102 so that the actuation wire 112slides through the collar and coaption element 110 during actuation toopen and close the paddles 120, 122 of the anchor portion 106.

Referring now to FIG. 11, the anchor portion 106 includes attachmentportions or gripping members. The illustrated gripping members arebarbed clasps 130 that include a base or fixed arm 132, a moveable arm134, barbs 136, and a joint portion 138. The fixed arms 132 are attachedto the inner paddles 122, with the joint portion 138 disposed proximatethe coaption element 110. The barbed clasps have flat surfaces and donot fit in a recess of the paddle. Rather, the flat portions of thebarbed clasps are disposed against the surface of the inner paddle 122.The joint portion 138 provides a spring force between the fixed andmoveable arms 132, 134 of the barbed clasp 130. The joint portion 138can be any suitable joint, such as a flexible joint, a spring joint, apivot joint, or the like. In certain embodiments, the joint portion 138is a flexible piece of material integrally formed with the fixed andmoveable arms 132, 134. The fixed arms 132 are attached to the innerpaddles 122 and remain stationary relative to the inner paddles 122 whenthe moveable arms 134 are opened to open the barbed clasps 130 andexpose the barbs 136. The barbed clasps 130 are opened by applyingtension to actuation lines 116 attached to the moveable arms 134,thereby causing the moveable arms 134 to pivot on the joint portions138.

During implantation, the paddles 120, 122 are opened and closed to graspthe native mitral valve leaflets between the paddles 120, 122 and thecoaption element 110. The barbed clasps 130 further secure the nativeleaflets by engaging the leaflets with barbs 136 and pinching theleaflets between the moveable and fixed arms 134, 132. The barbs 136 ofthe barbed clasps 130 increase friction with the leaflets or maypartially or completely puncture the leaflets. The actuation lines 116can be actuated separately so that each barbed clasp 130 can be openedand closed separately. Separate operation allows one leaflet to begrasped at a time, or for the repositioning of a clasp 130 on a leafletthat was insufficiently grasped, without altering a successful grasp onthe other leaflet. The barbed clasps 130 can be opened and closedrelative to the position of the inner paddle 122 (as long as the innerpaddle is in an open position), thereby allowing leaflets to be graspedin a variety of positions as the particular situation requires.

The barbed clasps 130 can be opened separately by pulling on an attachedactuation line 116 that extends through the delivery sheath 102 to thebarbed clasp 130. The actuation line 116 can take a wide variety offorms, such as, for example, a line, a suture, a wire, a rod, acatheter, or the like. The barbed clasps 130 can be spring loaded sothat in the closed position the barbed clasps 130 continue to provide apinching force on the grasped native leaflet. This pinching forceremains constant regardless of the position of the inner paddles 122.Barbs 136 of the barbed clasps 130 can pierce the native leaflets tofurther secure the native leaflets.

Referring now to FIG. 8, the device 100 is shown in an elongated orfully open condition for deployment from the delivery sheath. The device100 is loaded in the delivery sheath in the fully open position, becausethe fully open position takes up the least space and allows the smallestcatheter to be used (or the largest device 100 to be used for a givencatheter size). In the elongated condition the cap 114 is spaced apartfrom the coaption element 110 such that the paddles 120, 122 of theanchor portion 106 are fully extended. In some embodiments, an angleformed between the interior of the outer and inner paddles 120, 122 isapproximately 180 degrees. The barbed clasps 130 are kept in a closedcondition during deployment through the delivery sheath 102 so that thebarbs 136 (FIG. 11) do not catch or damage the sheath or tissue in thepatient's heart.

Referring now to FIG. 9, the device 100 is shown in an elongateddetangling condition, similar to FIG. 8, but with the barbed clasps 130in a fully open position, ranging from about 140 degrees to about 200degrees, to about 170 degrees to about 190 degrees, or about 180 degreesbetween fixed and moveable portions of the barbed clasps 130. Fullyopening the paddles 120, 122 and the clasps 130 has been found toimprove ease of detanglement from anatomy of the patient duringimplantation of the device 100.

Referring now to FIG. 10, the device 100 is shown in a shortened orfully closed condition. The compact size of the device 100 in theshortened condition allows for easier maneuvering and placement withinthe heart. To move the device 100 from the elongated condition to theshortened condition, the actuation wire 112 is retracted to pull the cap114 towards the coaption element 110. The joints or flexible connections126 between the outer paddle 120 and inner paddle 122 are constrained inmovement such that compression forces acting on the outer paddle 120from the cap 114 being retracted towards the coaption element 110 causethe paddles or gripping elements 120, 122 to move radially outward.During movement from the open to closed position, the outer paddles 120maintain an acute angle with the actuation wire 112. The outer paddles120 can optionally be biased toward a closed position. The inner paddles122 during the same motion move through a considerably larger angle asthey are oriented away from the coaption element 110 in the opencondition and collapse along the sides of the coaption element 110 inthe closed condition. In certain embodiments, the inner paddles 122 arethinner and/or narrower than the outer paddles 120, and the joint orflexible portions 126, 128 connected to the inner paddles 122 can bethinner and/or more flexible. For example, this increased flexibilitycan allow more movement than the joint or flexible portion 124connecting the outer paddle 124 to the cap 114. In certain otherembodiments, the outer paddles 120 are narrower than the inner paddles122. The joint or flexible portions 126, 128 connected to the innerpaddles 122 can be more flexible, for example, to allow more movementthan the joint or flexible portion 124 connecting the outer paddle 124to the cap 114. In yet another embodiment, the inner paddles 122 can bethe same or substantially the same width as the outer paddles (See forexample, FIG. 65A).

Referring now to FIGS. 11-13, the device 100 is shown in a partiallyopen, grasp-ready condition. To transition from the fully closed to thepartially open condition, the actuation wire 112 is extended to push thecap 114 away from the coaption element 110, thereby pulling on the outerpaddles 120, which in turn pulls on the inner paddles 122, causing theanchor portion 106 to partially unfold. The actuation lines 116 are alsoretracted to open the clasps 130 so that the leaflets can be grasped. Inthe example illustrated by FIG. 11, the pair of inner and outer paddles122, 120 are moved in unison, rather than independently, by a singleactuation wire 112. Also, the positions of the clasps 130 are dependenton the positions of the paddles 122, 120. For example, referring to FIG.10 closing the paddles 122, 120 also closes the clasps.

FIG. 11A illustrates an exemplary embodiment where the paddles 120, 122are independently controllable. The device 100A illustrated by FIG. 11Ais similar to the device illustrated by FIG. 11, except the device 100Aincludes two independent actuation wires 112A, 112B that are coupled totwo independent caps 114A, 114B. To transition a first inner paddle anda first outer paddle from the fully closed to the partially opencondition, the actuation wire 112A is extended to push the cap 114A awayfrom the coaption element 110, thereby pulling on the outer paddle 120,which in turn pulls on the inner paddle 122, causing the first anchorportion 106 to partially unfold. To transition a second inner paddle anda second outer paddle from the fully closed to the partially opencondition, the actuation wire 112B is extended to push the cap 114 awayfrom the coaption element 110, thereby pulling on the outer paddle 120,which in turn pulls on the inner paddle 122, causing the second anchorportion 106 to partially unfold. The independent paddle controlillustrated by FIG. 11A can be implemented on any of the devicesdisclosed by the present application.

Referring now to FIG. 12, one of the actuation lines 116 is extended toallow one of the clasps 130 to close. Referring now to FIG. 13, theother actuation line 116 is extended to allow the other clasp 130 toclose. Either or both of the actuation lines 116 may be repeatedlyactuated to repeatedly open and close the barbed clasps 130.

Referring now to FIG. 14, the device 100 is shown in a fully closed anddeployed condition. The delivery sheath 102 and actuation wire 112 areretracted and the paddles 120, 122 and clasps 130 remain in a fullyclosed position. Once deployed, the device 100 may be maintained in thefully closed position with a mechanical latch or may be biased to remainclosed through the use of spring materials, such as steel, other metals,plastics, composites, etc. or shape-memory alloys such as Nitinol. Forexample, the jointed or flexible portions 124, 126, 128, 138, and/or theinner and outer paddles 122, and/or an additional biasing component (seecomponent 524 in FIG. 28) may be formed of metals such as steel orshape-memory alloy, such as Nitinol—produced in a wire, sheet, tubing,or laser sintered powder—and are biased to hold the outer paddles 120closed around the coaption element 110 and the barbed clasps 130 pinchedaround native leaflets. Similarly, the fixed and moveable arms 132, 134of the barbed clasps 130 are biased to pinch the leaflets. In certainembodiments, the joint portions 124, 126, 128, 138, and/or the inner andouter paddles 122, and/or an additional biasing component (see component524 in FIG. 28) may be formed of any other suitably elastic material,such as a metal or polymer material, to maintain the device in theclosed condition after implantation.

Referring now to FIGS. 15-20, the implantable device 100 of FIGS. 8-14is shown being delivered and implanted within the native mitral valve MVof the heart H. Referring now to FIG. 15, the delivery sheath isinserted into the left atrium LA through the septum and the device 100is deployed from the delivery sheath in the fully open condition. Theactuation wire 112 is then retracted to move the device 100 into thefully closed condition shown in FIG. 16. As can be seen in FIG. 17, thedevice 100 is moved into position within the mitral valve MV into theventricle LV and partially opened so that the leaflets 20, 22 can begrasped. Referring now to FIG. 18, an actuation line 116 is extended toclose one of the clasps 130, capturing a leaflet 20. FIG. 19 shows theother actuation line 116 being then extended to close the other clasp130, capturing the remaining leaflet 22. Lastly, as can be seen in FIG.20, the delivery sheath 102 and actuation wire 112 and actuation lines116 are then retracted and the device 100 is fully closed and deployedin the native mitral valve MV.

Referring now to FIG. 21, an implantable prosthetic device 200 is shown.The device 200 includes an annular spacer member 202, a fabric cover(not shown), and anchors 204 extending from the spacer member 202. Theends of each anchor 204 can be coupled to respective struts of thespacer member 202 by respective sleeves 206 that can be crimped orwelded around the connection portions of the anchors 206 and the strutsof the spacer member 202. In another exemplary embodiment, a latchingmechanism can bind the spacer member 202 to the anchor 204 within thesleeve 206. For example, the sleeve can be machined to have an interiorshape that matches or is slightly smaller than the exterior shape of theends of the spacer member 202 and the anchor 204, so that the sleeve canbe friction fit on the connection portions. One or more barbs orprojections 208 can be mounted on the frame of the spacer member 202.The free ends of the barbs or projections 208 can comprise variousshapes including rounded, pointed, barbed, or the like. The projections208 can exert a retaining force against native leaflets by virtue of theanchors 204, which are shaped to force the native leaflets inwardly intothe spacer member 202.

Referring now to FIG. 22, an implantable prosthetic device 300 is shown.The prosthetic spacer device 300 includes an annular spacer member 302,a fabric cover (not shown), and anchors 304 extending from the spacermember 302 and can be configured similar to the prosthetic spacer device200. One or more barbs or projections 306 can be mounted on the frame ofthe spacer member 302. The ends of the projections 306 can comprisestoppers 308. The stoppers 308 of the projections can be configured in awide variety of different ways. For example, the stoppers 308 can beconfigured to limit the extent of the projections 306 that can engageand/or penetrate the native leaflets and/or the stoppers can beconfigured to prevent removal of the projections 306 from the tissueafter the projections 306 have penetrated the tissue.

The anchors 304 of the prosthetic spacer device 300 can be configuredsimilar to the anchors 204 of the prosthetic spacer device 200 exceptthat the curve of each anchor 304 comprises a larger radius than theanchors 204. As such, the anchors 304 cover a relatively larger portionof the spacer member 302 than the anchors 204. This can, for example,distribute the clamping force of the anchors 304 against the nativeleaflets over a relatively larger surface of the native leaflets inorder to further protect the native leaflet tissue.

Additional details regarding the prosthetic spacer devices can be found,for example, in U.S. Patent Application Publication No. 2016/0331523 andU.S. Provisional Application No. 62/161,688, which applications areincorporated by reference herein. The devices 200, 300 can include anyother features for an implantable prosthetic device discussed in thepresent application, and the device 200, 300 can be positioned to engagevalve tissue 20, 22 as part of any suitable valve repair system (e.g.,any valve repair system disclosed in the present application).

Referring now to FIGS. 23-27, an exemplary embodiment of an implantableprosthetic spacer device 400 is shown. The device 400 can include anyother features for an implantable prosthetic device discussed in thepresent application, and the device 400 can be positioned to engagevalve tissue 20, 22 as part of any suitable valve repair system (e.g.,any valve repair system disclosed in the present application).

Referring now to FIG. 23, the prosthetic spacer or coaption device 400can include a coaption portion 404 and an anchor portion 406, the anchorportion 406 including a plurality of anchors 408. The coaption portion404 includes a coaption or spacer member 410. The anchor portion 406includes a plurality of paddles 420 (e.g., two in the illustratedembodiment), and a plurality of clasps 430 (e.g., two in the illustratedembodiment). A first or proximal collar 411, and a second collar or cap414 are used to move the coaption portion 404 and the anchor portion 406relative to one another.

As shown in FIG. 25, first connection portions 425 of the anchors 408can be coupled to and extend from a first portion 417 of the coaption orspacer member 410, and second connection portions 421 of the anchors 408can be coupled to the first collar 414. The proximal collar 411 can becoupled to a second portion 419 of the coaption member 410.

The coaption member 410 and the anchors 408 can be coupled together invarious ways. For example, as shown in the illustrated embodiment, thecoaption member 410 and the anchors 408 can be coupled together byintegrally forming the coaption member 410 and the anchors 408 as asingle, unitary component. This can be accomplished, for example, byforming the coaption member 410 and the anchors 408 from a braided orwoven material, such as braided or woven nitinol wire. In otherembodiments, the coaption member 410 and the anchors 408 can be coupledtogether by welding, fasteners, adhesive, joint connections, sutures,friction fittings, swaging, and/or other means for coupling.

Referring now to FIG. 24, the anchors 408 can comprise first portions orouter paddles 420 and second portions or inner paddles 422 separated byjoint portions 423. In this manner, the anchors 408 are configuredsimilar to legs in that the inner paddles 422 are like upper portions ofthe legs, the outer paddles 420 are like lower portions of the legs, andthe joint portions 423 are like knee portions of the legs. In theillustrated example, the inner paddle portion 422, the outer paddleportion 420, and the joint portion 423 are formed from a continuousstrip of fabric, such as a metal fabric.

The anchors 408 can be configured to move between various configurationsby axially moving the cap 414 relative to the proximal collar 411 andthus the anchors 408 relative to the coaption member 410 along alongitudinal axis extending between the first or distal and second orproximal portions 417, 419 of the coaption member 410. For example, theanchors 408 can be positioned in a straight configuration by moving thecap 414 away from the coaption member 410. In the straightconfiguration, the paddle portions are aligned or straight in thedirection of the longitudinal axis of the device and the joint portions423 of the anchors 408 are adjacent the longitudinal axis of thecoaption member 410 (e.g., similar to the configuration shown in FIG.59). From the straight configuration, the anchors 408 can be moved to afully folded configuration (e.g., FIG. 23) by moving the toward thecoaption member 410. Initially as the cap 414 moves toward the coaptionmember 410, the anchors 408 bend at the joint portions 423, 425, 421 andthe joint portions 423 move radially outwardly relative to thelongitudinal axis of the coaption member 410 and axially toward thefirst portion 414 of the coaption member 410, as shown in FIGS. 24-25.As the cap 414 continues to move toward the coaption member 410, thejoint portions 423 move radially inwardly relative to the longitudinalaxis of the coaption member 410 and axially toward the proximal portion419 of the coaption member 410, as shown in FIG. 23.

In some embodiments, an angle between the inner paddles 422 of theanchors 408 and the coaption member 410 can be approximately 180 degreeswhen the anchors 408 are in the straight configuration (see, e.g., FIG.59), and the angle between the inner paddles 422 of the anchors 408 andthe coaption member 410 can be approximately 0 degrees when the anchors408 are in the fully folded configuration (See FIG. 23). The anchors 408can be positioned in various partially folded configurations such thatthe angle between the inner paddles 422 of the anchors 408 and thecoaption member 410 can be approximately 10-170 degrees or approximately45-135 degrees.

Configuring the prosthetic spacer device 400 such that the anchors 408can extend to a straight or approximately straight configuration (e.g.approximately 120-180 degrees relative to the coaption member 410) canprovide several advantages. For example, this can reduce the radialcrimp profile of the prosthetic spacer device 400. It can also make iteasier to grasp the native leaflets by providing a larger opening inwhich to grasp the native leaflets. Additionally, the relatively narrow,straight configuration can prevent or reduce the likelihood that theprosthetic spacer device 400 will become entangled in native anatomy(e.g., chordae tendineae) when positioning and/or retrieving theprosthetic spacer device 400 into the delivery apparatus.

Referring again to FIG. 24, the clasps 430 can comprise attachment orfixed portions 432 and arm or moveable portions 434. The attachment orfixed portions 432 can be coupled to the inner paddles 422 of theanchors 408 in various ways such as with sutures, adhesive, fasteners,welding, stitching, swaging, friction fit and/or other means forcoupling.

The moveable portions 434 can pivot relative to the fixed portions 432between an open configuration (e.g., FIG. 24) and a closed configuration(FIGS. 23 and 25). In some embodiments, the clasps 430 can be biased tothe closed configuration. In the open configuration, the fixed portions432 and the moveable portions 434 pivot away from each other such thatnative leaflets can be positioned between the fixed portions 432 and themoveable portions 434. In the closed configuration, the fixed portions432 and the moveable portions 434 pivot toward each other, therebyclamping the native leaflets between the fixed portions 432 and themoveable portions 434.

Referring to FIGS. 26-27, the fixed portions 432 (only one shown inFIGS. 26-27) can comprise one or more openings 433 (e.g., three in theillustrated embodiment). At least some of the openings 433 can be usedto couple the fixed portions 432 to the anchors 408. For example,sutures and/or fasteners can extend through the openings 433 to couplethe fixed portions 432 to the anchors 408 or other attachments, such aswelding, adhesives, etc. can be used.

The moveable portions 434 can comprise one or more side beams 431. Whentwo side beams are included as illustrated, the side beams can be spacedapart to form slots 431A. The slots 431A can be configured to receivethe fixed portions 432. The moveable portions 434 can also includespring portions 434A that are coupled to the fixed portions 432 and barbsupport portions 434B disposed opposite the spring portions 434A.

The barb support portions portions 434B can comprise gripper orattachment elements such as barbs 436 and/or other means forfrictionally engaging native leaflet tissue. The gripper elements can beconfigured to engage and/or penetrate the native leaflet tissue to helpretain the native leaflets between the fixed portions 432 and moveableportions 434 of the clasps 430.

The barb support portions 434B can also comprise eyelets 435, which canbe used to couple the barb support portions 434B to an actuationmechanism configured to pivot the moveable portions 434 relative to thefixed portions 432. Additional details regarding coupling the clasps 430to the actuation mechanism are provided below.

In some embodiments, the clasps 430 can be formed from a shape memorymaterial such as nitinol, stainless steel, and/or shape memory polymers.In certain embodiments, the clasps 430 can be formed by laser-cutting apiece of flat sheet material (e.g., nitinol) or a tube in theconfiguration shown in FIG. 26 or a similar or different configurationand then shape-setting the clasp 430 in the configuration shown in FIG.27.

Shape-setting the clasps 430 in this manner can provide severaladvantages. For example, the clasps 430 can optionally be compressedfrom the shape-set configuration (e.g., FIG. 27) to the flatconfiguration (e.g., FIG. 26), or another configuration which reducesthe radial crimp profile of the clasps 430. For example, the barbs canoptionally be compressed to a flat configuration. Reducing the radialcrimp profile can improve trackability and retrievability of theprosthetic spacer device 400 relative to a catheter shaft of a deliveryapparatus because barbs 440 are pointing radially inwardly toward theanchors 408 when the prosthetic spacer device 400 is advanced through orretrieved into the catheter shaft (see, e.g., FIG. 33). This can preventor reduce the likelihood that the clasps 430 may snag or skive thecatheter shaft.

In addition, shape-setting the clasps 430 in the configuration shown inFIG. 27 can increase the clamping force of the clasps 430 when theclasps 430 are in the closed configuration. This is because the moveableportions 434 are shape-set relative to the fixed portions 432 to a firstposition (e.g., FIG. 27) which is beyond the position the moveableportions 434 can achieve when the clasps 430 are attached to the anchors408 (e.g., FIG. 25) because the anchors 408 prevent the moveableportions 434 from further movement toward the shape-set configuration.This results in moveable portions 434 having a preload (i.e., theclamping force is greater than zero) when the clasps 430 are attached tothe anchors 408 and in the closed configuration. Thus, shape-setting theclasps 430 in the FIG. 27 configuration can increase the clamping forceof the clasps 430 compared to clasps that are shape-set in the closedconfiguration.

The magnitude of the preload of the clasps 430 can be altered byadjusting the angle in which the moveable portions 434 are shape-setrelative to the fixed portions 432. For example, increasing the relativeangle between the moveable portions 434 and the fixed portions 432increases the preload, and decreasing the relative angle between themoveable portions 434 and the fixed portions 432 decreases the preload.

In some embodiments, the proximal collar 411 and/or the coaption member410 can comprise a hemostatic seal 413 configured to reduce or preventblood from flowing through the proximal collar 411 and/or the coaptionmember 410. For example, in some embodiments, the hemostatic seal 413can comprise a plurality of flexible flaps 413A, as shown in FIG. 23.The flaps 413A can be configured to pivot from a sealed configuration toan open configuration to allow a shaft of a delivery apparatus to extendthrough the second collar 410. In one exemplary embodiment, the flaps413A form a seal around the shaft of the delivery apparatus. When theshaft of the delivery apparatus is removed, the flaps 413A can beconfigured to return to the sealed configuration from the openconfiguration.

Referring now to FIGS. 28-30, an exemplary embodiment of an implantableprosthetic spacer device 500 is shown. The implantable device 500 is oneof the many different configurations that the device 100 that isschematically illustrated in FIGS. 8-20 can take. The device 500 caninclude any other features for an implantable prosthetic devicediscussed in the present application, and the device 500 can bepositioned to engage valve tissue 20, 22 as part of any suitable valverepair system (e.g., any valve repair system disclosed in the presentapplication).

The prosthetic spacer device 500 can comprise a coaption element orspacer member 510, a plurality of anchors 508 that include outer paddles520, inner paddles 522, clasps 530, a first or proximal collar 511, anda second collar or cap 514. These components of the prosthetic spacerdevice 500 can be configured substantially similar to the correspondingcomponents of the prosthetic spacer device 400.

The prosthetic spacer device 500 can also include a plurality of paddleextension members or paddle frames 524. The paddle frames 524 can beconfigured with a round three-dimensional shape with first connectionportions 526 coupled to and extending from the cap 514 and secondconnection portions 528 disposed opposite the first connection portions526. The paddle frames 524 can be configured to extend circumferentiallyfarther around the coaption member 510 than the outer paddles 520. Forexample, in some embodiments, each of the paddle frames 524 can extendaround approximately half of the circumference of the coaption member510 (as shown in FIG. 29), and the outer paddles 520 can extend aroundless than half of the circumference of the coaption member 510 (as shownin FIG. 28). The paddle frames 524 can also be configured to extendlaterally (i.e., perpendicular to a longitudinal axis of the coaptionmember 510) beyond an outer diameter of the coaption member 510. In theillustrated example, the inner paddle portions 522 and the outer paddleportions 520 are formed from a continuous strip of fabric that areconnected to the paddle frames 524. For example, the inner paddleportions and the outer paddle portions can be connected to theconnection portion of the paddle frame at the flexible connectionbetween the inner paddle portion and the outer paddle portion.

The paddle frames 524 can further be configured such that connectionportions 528 of the paddle frames 524 are connected to or axiallyadjacent a joint portion 523. The connection portions of the paddleframes 534 can be positioned between outer and inner paddles 520, 522,on the outside of the paddle portion 520, on the inside of the innerpaddle portion, or on top of the joint portion 523 when the prostheticspacer device 500 is in a folded configuration (e.g., FIGS. 28-30). Theconnections between the paddle frames 524, the single strip that formsthe outer and inner paddles 520, 522, the cap 514, and the coaptionelement can constrain each of these parts to the movements and positionsdescribed herein. In particular the joint portion 523 is constrained byits connection between the outer and inner paddles 520, 522 and by itsconnection to the paddle frame. Similarly, the paddle frame 524 isconstrained by its attachment to the joint portion 523 (and thus theinner and outer paddles) and to the cap.

Configuring the paddle frames 524 in this manner provides increasedsurface area compared to the outer paddles 520 alone. This can, forexample, make it easier to grasp and secure the native leaflets. Theincreased surface area can also distribute the clamping force of thepaddles 520 and paddle frames 524 against the native leaflets over arelatively larger surface of the native leaflets in order to furtherprotect the native leaflet tissue.

The increased surface area of the paddle frames 524 can also allow thenative leaflets to be clamped to the prosthetic spacer device 500, suchthat the native leaflets coapt entirely around the coaption member 510.This can, for example, improve sealing of the native leaflet and thusprevent or further reduce mitral regurgitation.

Referring to FIG. 30, the prosthetic spacer device 500 can also includea cover 540. In some embodiments, the cover 540 can be disposed on thecoaption member 510, the paddles 520, 522, and/or the paddle frames 524.The cover 540 can be configured to prevent or reduce blood-flow throughthe prosthetic spacer device 500 and/or to promote native tissueingrowth. In some embodiments, the cover 540 can be a cloth or fabricsuch as PET, velour, or other suitable fabric. In other embodiments, inlieu of or in addition to a fabric, the cover 540 can include a coating(e.g., polymeric) that is applied to the prosthetic spacer device 500.

FIGS. 31-32 illustrate the implantable prosthetic device 500 of FIGS. 28and 29 with anchors 508 of an anchor portion 506 and clasps 530 in openpositions. The device 500 is deployed from a delivery sheath (not shown)and includes a coaption portion 504 and the anchor portion 506. Thedevice 500 is loaded in the delivery sheath in the fully extended orbailout position, because the fully extended or bailout position takesup the least space and allows the smallest catheter to be used (See FIG.35). Or, the fully extended position allows the largest device 500 to beused for a given catheter size. The coaption portion 504 of the deviceincludes a coaption element 510 for implantation between the leaflets ofthe native mitral valve. An insert 516A is disposed inside the coaptionelement 510. The insert 516A and the coaption element 510 are slidablyattached to an actuation wire or shaft 512. The anchors 508 of thedevice 500 include outer paddles 520 and inner paddles 522 that areflexibly connected to the cap 514 and the coaption element 510.Actuation of the actuation wire or shaft 512 opens and closes theanchors 508 of the device 500 to grasp the mitral valve leaflets duringimplantation.

The actuation wire 512 extends through the delivery sheath (not shown),the proximal collar 511, the coaption element 510, the insert 516A, andextends to the cap 514. Extending and retracting the actuation wire 512increases and decreases the spacing between the coaption element 510 andthe cap 514, respectively. This changing of the spacing between thecoaption element 510 and the cap 514 causes the anchor portion 506 ofthe device to move between different positions.

The proximal collar 511 optionally includes a collar seal 513 that formsa seal around the actuation wire or shaft 512 during implantation of thedevice 500, and that seals shut when the actuation wire 512 is removedto substantially close the proximal end of the device 500 to blood flowthrough the interior of the coaption element 510 after implantation. Insome embodiments, a coupler 2214 (see FIG. 145) removably engages andattaches the proximal collar 511 and the coaption element 500 to thedelivery sheath. In some embodiments, coupler 2214 is held closed aroundthe proximal collar 511 by the actuation wire 512, such that removal ofthe actuation wire 512 allows fingers (see FIG. 145) of the coupler 2214to open, releasing the proximal collar 511.

The proximal collar 511 and the insert 516A in the coaption element 510slide along the actuation wire 512 during actuation to open and closethe paddles 520, 522 of the anchors 508. Referring to FIGS. 32A and 32B,in some embodiments the cap 514 optionally includes a sealing projection516 that sealingly fits within a sealing opening 517 of the insert 516A.In another exemplary embodiment, the cap 514 includes a sealing openingand the insert 516A includes a sealing projection. The insert 516A cansealingly fit inside a distal opening 515 of the coaption element 510,the coaption element 510 having a hollow interior. Referring to FIG.32A, the sealing projection 516 of the cap 514 sealingly engages theopening 517 in the insert 516A to maintain the distal end of thecoaption element 510 substantially closed to blood flow when the device500 is implanted and/or in the closed position.

In another exemplary embodiment, instead of the sealing engagementbetween the cap 514 and the insert 516A, the insert 516A can optionallyinclude a seal, like the collar seal 513 of the proximal collar, thatforms a seal around the actuation wire or shaft 512 during implantationof the device 500, and that seals shut when the actuation wire 512 isremoved. Such a seal can substantially close the distal end of thecoaption element 510 to blood flow after implantation.

The coaption element 510 and paddles 520, 522 are formed from a flexiblematerial that may be a metal fabric, such as a mesh, woven, braided, orformed in any other suitable way or a laser cut or otherwise cutflexible material. The material may be cloth, shape-memory alloywire—such as Nitinol—to provide shape setting capability, or any otherflexible material suitable for implantation in the human body. Paddleframes 524 provide additional pinching force between the inner paddles522 and the coaption element 510 and assist in wrapping the leafletsaround the sides of the coaption element 510 for a better seal betweenthe coaption element 510 and the leaflets. In some embodiments, thecovering 540 illustrated by FIG. 30 extends around the paddle frames524.

The clasps 530 include a base or fixed arm 532, a moveable arm 534,barbs 536, and a joint portion 538. The fixed arms 532 are attached tothe inner paddles 522, with the joint portion 538 disposed proximate thecoaption element 510. The barbed clasps have flat surfaces and do notfit in a recess of the paddle. Rather, the flat portion of the barbedclasps are disposed against the surface of the inner paddle 522. Forexample, the fixed arms 532 are attached to the inner paddles 522through holes or slots 533 with sutures (not shown). The fixed arms 532may be attached to the inner paddles 522 with any suitable means, suchas screws or other fasteners, crimped sleeves, mechanical latches orsnaps, welding, adhesive, or the like. The fixed arms 532 remainsubstantially stationary relative to the inner paddles 522 when themoveable arms 534 are opened to open the barbed clasps 530 and exposethe barbs 536. The barbed clasps 530 are opened by applying tension toactuation lines (not shown) attached to holes 535 in the moveable arms534, thereby causing the moveable arms 534 to pivot on the jointportions 538.

During implantation, the anchors 508 are opened and closed to grasp thenative mitral valve leaflets between the paddles 520, 522 and thecoaption element 510. The barbed clasps 530 further secure the nativeleaflets by engaging the leaflets with barbs 536 and pinching theleaflets between the moveable and fixed arms 534, 532. The barbs 536 ofthe barbed clasps 530 increase friction with the leaflets or maypartially or completely puncture the leaflets. The actuation lines canbe actuated separately so that each barbed clasp 530 can be opened andclosed separately. Separate operation allows one leaflet to be graspedat a time, or for the repositioning of a clasp 530 on a leaflet that wasinsufficiently grasped, without altering a successful grasp on the otherleaflet. The barbed clasps 530 can open and close when the inner paddle522 is not closed, thereby allowing leaflets to be grasped in a varietyof positions as the particular situation requires.

Referring now to FIG. 33, an exemplary barbed clasp 600 for use inimplantable prosthetic devices, such as the devices described above, isshown. However, a wide variety of different barbed clasps can be used.Examples of barbed clasps that can be used include, but are not limitedto any of the barbed clasps disclosed in the present application and anyof the applications that are incorporated herein by reference and/orthat the present application claims priority to. In the illustratedexample, the barbed clasp 600 is formed from a top layer 602 and abottom layer 604. The two-layer design of the clasp 600 allow thinnersheets of material to be used, thereby improving the flexibility of theclasp 600 over a clasp formed from a single thicker sheet, whilemaintaining the strength of the clasp 600 needed to successfully retaina native valve leaflet.

The barbed clasp 600 includes a fixed arm 610, a jointed portion 620,and a movable arm 630 having a barbed portion 640. The top and bottomlayers 602, 604 have a similar shape and in certain embodiments areattached to each other at the barbed portion 640. However, the top andbottom layers 602, 604 can be attached to one another at other oradditional locations. The jointed portion 620 is spring-loaded so thatthe fixed and moveable arms 610, 630 are biased toward each other whenthe barbed clasp 600 is in a closed condition. When assembled to animplantable prosthetic device, the fixed arm 610 is attached to aportion of the prosthetic device. The clasp 600 is opened by pulling onan actuation line attached to the moveable arm 630 until the springforce of the joint portion 620 is overcome.

The fixed arm 610 is formed from a tongue 611 of material extending fromthe jointed portion 620 between two side beams 631 of the moveable arm630. The tongue 611 is biased between the side beams 631 by the jointportion 620 such that force must be applied to move the tongue 611 froma neutral position located beyond the side beams 631 to a preloadedposition substantially parallel with the side beams 631. The tongue 611is held in the preloaded position by an optional T-shaped cross-bar 614that is attached to the tongue 611 and extends outward to engage theside beams 631. In another exemplary embodiment, the cross-bar isomitted and the tongue 611 is attached to the inner paddle 522, and theinner paddle 522 maintains the clasp in the preloaded position. In thetwo-layer clasp application, the top and bottom layers 602, 604 or justthe top layer can be attached to the inner paddle. In some embodiments,the angle between the fixed and moveable arms 610, 630 when the tongueis in the neutral position is about 30 to about 100 degrees, 30 to about90 degrees, or about 30 to about 60 degrees, or about 40 to about 50degrees, or about 45 degrees.

The tongue 611 includes holes 612 for receiving sutures (not shown) thatattach the fixed arm 610 to an implantable device. The fixed arm 610 maybe attached to an implantable device, such as with screws or otherfasteners, crimped sleeves, mechanical latches or snaps, welding,adhesive, or the like. In certain embodiments, the holes 612 areelongated slots or oval-shaped holes to accommodate sliding of thelayers 602, 604 without damaging the sutures attaching the clasp 600 toan implantable device.

The joint portion 620 is formed by two beam loops 622 that extend fromthe tongue 611 of the fixed arm 610 to the side beams 631 of themoveable arm 630. In certain embodiments, the beam loops 622 arenarrower than the tongue 611 and side beam 631 to provide additionalflexibility. The beam loops 622 each include a center portion 624extending from the tongue 611 and an outer portion 626 extending to theside beams 631. The beam loops 622 are bent into a somewhat spiral orhelical shape by bending the center and outer portions 624, 626 inopposite directions, thereby forming an offset or step distance 628between the tongue 611 and side beams 631. The step distance 628provides space between the arms 610, 630 to accommodate the nativeleaflet of the mitral valve after it is grasped. In certain embodiments,the step distance 628 is about 0.5 millimeter to about 1 millimeters, orabout 0.75 millimeters.

When viewed in a top plan view, the beam loops have an “omega-like”shape. This shape of the beam loops 622 allows the fixed and moveablearms 610, 630 to move considerably relative to each other withoutplastically deforming the clasp material. For example, in certainembodiments, the tongue 611 can be pivoted from a neutral position thatis approximately 45 degrees beyond the moveable arm 630 to a fully openposition that ranges from about 140 degrees to about 200 degrees, toabout 170 degrees to about 190 degrees, or about 180 degrees from themoveable arm 630 without plastically deforming the clasp material. Incertain embodiments, the clasp material plastically deforms duringopening without reducing or without substantially reducing the pinchforce exerted between the fixed and moveable arms in the closedposition.

Preloading the tongue 611 enables the clasp 600 to maintain a pinchingor clipping force on the native leaflet when closed. The preloading ofthe tongue 611 provides a significant advantage over prior art clipsthat provide little or no pinching force when closed. Additionally,closing the clasp 600 with spring force is a significant improvementover clips that use a one-time locking closure mechanism, as the clasp600 can be repeatedly opened and closed for repositioning on the leafletwhile still maintaining sufficient pinching force when closed. Inaddition, the spring-loaded clasps also allow for easier removal of thedevice over time as compared to a device that locks in a closed position(after tissue ingrowth). In one exemplary embodiment, both the claspsand the paddles are spring biased to their closed positions (as opposedto being locked in the closed position), which can allow for easierremoval of the device after tissue ingrowth.

The barbed portion 640 of the moveable arm 630 includes an eyelet 642,barbs 644, and barb supports 646. Positioning the barbed portion of theclasp 600 toward an end of the moveable arm 630 increases the spacebetween the barbs 644 and the fixed arm 610 when the clasp 600 isopened, thereby improving the ability of the clasp 600 to successfullygrasp a leaflet during implantation. This distance also allows the barbs644 to more reliably disengage from the leaflet for repositioning. Incertain embodiments, the barbs of the clasps may be staggeredlongitudinally to further distribute pinch forces and local leafletstress.

The barbs 644 are laterally spaced apart at the same distance from thejoint portion 620, providing a superior distribution of pinching forceson the leaflet tissue while also making the clasp more robust to leafletgrasp than barbs arranged in a longitudinal row. In some embodiments,the barbs 644 can be staggered to further distribute pinch forces andlocal leaflet stress.

The barbs 644 are formed from the bottom layer 604 and the barb supports646 are formed from the top layer. In certain embodiments, the barbs areformed from the top layer 602 and the barb supports are formed from thebottom layer 604. Forming the barbs 644 only in one of the two layers602, 604 allows the barbs to be thinner and therefore effectivelysharper than a barb formed from the same material that is twice asthick. The barb supports 646 extend along a lower portion of the barbs644 to stiffen the barbs 644, further improving penetration andretention of the leaflet tissue. In certain embodiments, the ends of thebarbs 644 are further sharpened using any suitable sharpening means.

The barbs 644 are angled away from the moveable arm 630 such that theyeasily penetrate tissue of the native leaflets with minimal pinching orclipping force. The barbs 644 extend from the moveable arm at an angleof about 45 degrees to about 75 degrees, or about 45 degrees to about 60degrees, or about 48 to about 56 degrees, or about 52 degrees. The angleof the barbs 644 provides further benefits, in that force pulling theimplant off the native leaflet will encourage the barbs 644 to furtherengage the tissue, thereby ensuring better retention. Retention of theleaflet in the clasp 600 can be further improved by the position of theT-shaped cross bar 614 near the barbs 644 when the clasp 600 is closed.In this arrangement, the tissue pierced by the barbs 644 is pinchedagainst the moveable arm 630 at the cross bar 614 location, therebyforming the tissue into an S-shaped torturous path as it passes over thebarbs 644. Thus, forces pulling the leaflet away from the clasp 600 willencourage the tissue to further engage the barbs 644 before the leafletscan escape. For example, leaflet tension during diastole can encouragethe barbs to pull toward the end portion of the leaflet. The S-shapedpath can utilize the leaflet tension during diastole to more tightlyengage the leaflets with the barbs.

Each layer 602, 604 of the clasp 600 is laser cut from a sheet ofshape-memory alloy, such as Nitinol. The top layer 602 is aligned andattached to the bottom layer 604. In certain embodiments, the layers602, 604 are attached at the barbed portion 640 of the moveable arm 630.For example, the layers 602, 604 may be attached only at the barbedportion 640, to allow the remainder of the layers to slide relative toone another. Portions of the combined layers 602, 604, such as a fixedarm 610, barbs 644 and barb supports 646, and beam loops 622 are bentinto a desired position. The layers 602, 604 may be bent and shapesettogether or may be bent and shapeset separately and then joinedtogether. The clasp 600 is then subjected to a shape-setting process sothat internal forces of the material will tend to return to the setshape after being subjected to deformation by external forces. Aftershape setting, the tongue 611 is moved to its preloaded position so thatthe cross-bar 614 can be attached. In one exemplary embodiment, theclasp 600 can optionally be completely flattened for delivery through adelivery sheath and allowed to expand once deployed within the heart.The clasp 600 is opened and closed by applying and releasing tension onan actuation line, suture, wire, rod, catheter, or the like (not shown)attached to the moveable arm 630. The suture is inserted through aneyelet 642 near the barbed portion 640 of the moveable arm 630 and wrapsaround the moveable arm 630 before returning to the delivery sheath. Incertain embodiments, an intermediate suture loop is made through theeyelet and the suture is inserted through the intermediate loop. Analternate embodiment of the intermediate loop can be composed of fabricor another material attached to the movable arm, instead of a sutureloop.

An intermediate loop of suture material reduces friction experienced bythe actuation suture relative to the friction between the actuationsuture and the clasp material. When the suture is looped through theeyelet 642 or intermediate loop, both ends of the actuation sutureextend back into and through a delivery sheath (e.g., FIG. 8). Thesuture can be removed by pulling one end of the suture proximally untilthe other end of the suture pulls through the eyelet or intermediateloop and back into the delivery sheath.

Referring now to FIG. 34, a close-up view of one of the leaflets 20, 22grasped by a barbed clasp such as clasps 430, 530 is shown. The leaflet20, 22 is grasped between the moveable and fixed arms 434, 534 of theclasp 430, 530. As shown in FIG. 34, the tissue of the leaflet 20, 22 isnot pierced by the barbs 436, 536, though in some embodiments the barbs436, 536 may partially or fully pierce through the leaflet 20, 22. Theangle and height of the barbs 436, 536 relative to the moveable arm 434,534 helps to secure the leaflet 20, 22 within the clasp 430, 530. Inparticular, a force pulling the implant off of the native leaflet willencourage the barbs 436, 536 to further engage the tissue, therebyensuring better retention. Retention of the leaflet 20, 22 in the clasp430, 530 is further improved by the position of fixed arm 432, 532 nearthe barbs 436, 536 when the clasp 430, 530 is closed. In thisarrangement, the tissue is formed by the fixed arms 432, 532 and themoveable arms 434, 534 and the barbs 436, 536 into an S-shaped torturouspath. Thus, forces pulling the leaflet away from the clasp 430, 530 willencourage the tissue to further engage the barbs 436, 536 before theleaflets can escape. For example, as mentioned above, leaflet tensionduring diastole can encourage the barbs to pull toward the end portionof the leaflet. The S-shaped path can utilize the leaflet tension duringdiastole to more tightly engage the leaflets with the barbs.

Referring now to FIGS. 35-46, the implantable device 500 is shown beingdelivered and implanted within the native mitral valve MV of the heartH. As described above, the device 500 has a covering 540 (see FIG. 30)over the coaption element 510, clasps 530, inner paddles 522 and/or theouter paddles 520. The device 500 is deployed from a delivery sheath 502and includes a coaption portion 504 and an anchor portion 506 includinga plurality of anchors 508 (i.e., two in the illustrated embodiment).The coaption portion 504 of the device includes a coaption element 510for implantation between the leaflets 20, 22 of the native mitral valveMV that is slidably attached to an actuation wire or shaft 512.Actuation of the actuation wire or shaft 512 opens and closes theanchors 508 of the device 500 to grasp the mitral valve leaflets 20, 22during implantation.

The anchors 508 of the device 500 include outer paddles 520 and innerpaddles 522 that are flexibly connected to the cap 514 and the coaptionelement 510. The actuation wire 512 extends through a capture mechanism503 (see FIG. 41), delivery sheath 502, and the coaption element 510 tothe cap 514 connected to the anchor portion 506. Extending andretracting the actuation wire 512 increases and decreases the spacingbetween the coaption element 510 and the cap 514, respectively. In theexample illustrated by FIGS. 35-46, the pair of inner and outer paddles522, 520 are moved in unison, rather than independently, by a singleactuation wire 512. Also, the positions of the clasps 530 are dependenton the positions of the paddles 522, 520. For example, referring to FIG.45 closing the paddles 522, 520 also closes the clasps. In one exemplaryembodiment, the device 500 can be made to have the paddles 520, 522 beindependently controllable in the same manner as the FIG. 11Aembodiment.

Fingers of the capture mechanism 503 removably attach the collar 511 tothe delivery sheath 502. The collar 511 and the coaption element 510slide along the actuation wire 512 during actuation to open and closethe anchors 508 of the anchor portion 506. In some embodiments, thecapture mechanism 503 is held closed around the collar 511 by theactuation wire 512, such that removal of the actuation wire 512 allowsthe fingers of the capture mechanism 503 to open, releasing the collar511, and thus the coaption element 510.

The coaption element 510 and paddles 520, 522 can be formed from aflexible material that may be a metal fabric, such as a mesh, woven,braided, or formed in any other suitable way or a laser cut or otherwisecut flexible material. The flexible material may be cloth, shape-memoryalloy wire—such as Nitinol—to provide shape setting capability, or anyother flexible material suitable for implantation in the human body.

The barbed clasps 530 include a base or fixed arm 532, a moveable arm534, barbs 536 (see FIG. 41), and a joint portion 538. The fixed arms532 are attached to the inner paddles 522, with the joint portions 538disposed proximate the coaption element 510. Sutures (not shown) attachthe fixed arms 532 to the inner paddles 522. The fixed arms 532 may beattached to the inner paddles 522 with any suitable means, such asscrews or other fasteners, crimped sleeves, mechanical latches or snaps,welding, adhesive, or the like. The fixed arms 532 remain substantiallystationary when the moveable arms 534 are opened to open the barbedclasps 530 and expose the barbs 536. The barbed clasps 530 are opened byapplying tension to actuation lines 537 attached to the moveable arms534, thereby causing the moveable arms 534 to pivot on the jointportions 538.

During implantation, the anchors 508 are opened and closed to grasp thenative mitral valve leaflets between the paddles 520, 522 and thecoaption element 510. The outer paddles 520 have a wide curved shapethat fits around the curved shape of the coaption element 510 to moresecurely grip the leaflets 20, 22. The curved shape and rounded edges ofthe outer paddle 520 also prohibits tearing of the leaflet tissue. Thebarbed clasps 530 further secure the native leaflets by engaging theleaflets with barbs 536 and pinching the leaflets between the moveableand fixed arms 534, 532. The barbs 536 of the barbed clasps 530 increasefriction with the leaflets or may partially or completely puncture theleaflets. The actuation lines can be actuated separately so that eachbarbed clasp 530 can be opened and closed separately. Separate operationallows one leaflet to be grasped at a time, or for the repositioning ofa clasp 530 on a leaflet that was insufficiently grasped, withoutaltering a successful grasp on the other leaflet. The barbed clasps 530can be fully opened and closed when the inner paddle 522 is not closed,thereby allowing leaflets to be grasped in a variety of positions as theparticular situation requires.

The device 500 is loaded in the delivery sheath in the fully openposition, because the fully open position takes up the least space andallows the smallest catheter to be used (or the largest device 500 to beused for a given catheter size). Referring now to FIG. 35, the deliverysheath is inserted into the left atrium LA through the septum and thedevice 500 is deployed from the delivery sheath 502 in the fully opencondition. The actuation wire 512 is then retracted to move the device500 into the fully closed condition shown in FIGS. 36-37 and thenmaneuvered towards the mitral valve MV as shown in FIG. 38. Referringnow to FIG. 39, when the device 500 is aligned with the mitral valve MV,the actuation wire 512 is extended to open the paddles 520, 522 into thepartially opened position and the actuation lines 537 are retracted toopen the barbed clasps 530 to prepare for leaflet grasp. Next, as shownin FIGS. 40-41, the partially open device 500 is inserted through themitral valve MV until leaflets 20, 22 are properly positioned in betweenthe inner paddles 522 and the coaption element 510 and inside the openbarbed clasps 530. FIG. 42 shows the device 500 with both clasps 530closed, though the barbs 536 of one clasp 530 missed one of the leaflets22. As can be seen in FIGS. 42-44, the out of position clasp 530 isopened and closed again to properly grasp the missed leaflet 22. Whenboth leaflets 20, 22 are grasped properly, the actuation wire 512 isretracted to move the device 500 into the fully closed position shown inFIG. 45. With the device 500 fully implanted in the native mitral valveMV, the actuation wire 512 is withdrawn to release the capture mechanism503 from the proximal collar 511. Once deployed, the device 500 may bemaintained in the fully closed position with a mechanical means such asa latch or may be biased to remain closed through the use of springmaterial, such as steel, and/or shape-memory alloys such as Nitinol. Forexample, the paddles 520, 522 may be formed of steel or Nitinolshape-memory alloy—produced in a wire, sheet, tubing, or laser sinteredpowder—and are biased to hold the outer paddles 520 closed around theinner paddles 522, coaption element 510, and the barbed clasps 530pinched around native leaflets 20, 22.

The device 500 can have a wide variety of different shapes and sizes.Referring to FIGS. 6 and 6A-6E, in an exemplary embodiment, the coaptionelement 510 functions as a gap filler in the valve regurgitant orifice,such as the gap 26 in the mitral valve MV illustrated by FIG. 6.Referring to FIG. 6A, since the coaption element 510 is deployed betweentwo opposing valve leaflets 20, 22, the leaflets will not coapt againsteach other in the area of the coaption element 510, but coapt againstthe coaption element 510 instead. This reduces the distance the leaflets20, 22 need to be approximated. A reduction in leaflet approximationdistance can result in several advantages. For example, the coaptionelement and resulting reduced approximation can facilitate repair ofsevere mitral valve anatomies, such as large gaps in functional valvedisease (See for example, FIG. 6). Since the coaption element 510reduces the distance the native valves have to be approximated, thestress in the native valves can be reduced or minimized Shorterapproximation distance of the valve leaflets 20, 22 can require lessapproximation forces which can result in less tension of the leafletsand less diameter reduction of the valve annulus. The smaller reductionof the valve annulus (or no reduction of the valve annulus) can resultin less reduction in valve orifice area as compared to a device withouta spacer. As a result, the coaption element 510 can reduce thetransvalvular gradients.

In one exemplary embodiments, the paddle frames 524 conform to the shapeof the coaption element 510. In one example, if the copation element 510is wider than the paddle frames 524, a distance (gap) between theopposing leaflets 20,22 can be created by the device 500. Referring toFIGS. 6A-6E, in one exemplary embodiment the paddles are configured toconform to the shape or geometry of the coaption element 510. As aresult, the paddles can mate with both the coaption element 510 and thenative valve. Referring to FIGS. 6D and 6E, in one exemplary embodimentthe paddles 524 surround the coaption element 510. Thus, when theleaflets 20, 22 are coapted against the coaption element 510, theleaflets 20, 2 fully surround or “hug” the coaption element 510 in itsentirely, thus small leaks on the medial and lateral aspects of thecoaption element 510 an be prevented. FIGS. 6B and 6C illustrate thevalve repair device 500 attached to mitral valve leaflets 20, 22 fromthe ventricular side of the mitral valve. FIG. 6A illustrates the valverepair device 500 attached to mitral valve leaflets 20, 22 from theatrial side of the mitral valve. Referring to FIGS. 6A and 6B, when thepaddles have a geometry that conforms to the geometry of the coaptionelement 510, the leaflets 20, 22 can coapt around the coaption elementand/or along the length of the spacer. Referring to FIG. 6E, a schematicatrial view/surgeons view depicts the paddle frames (which would notactually be visible from a true atrial view), conforming to the spacergeometry. The opposing leaflets 20, 22 (the ends of which would also notbe visible in the true atrial view) being approximated by the paddles,to fully surround or “hug” the coaption element 510.

Referring to FIGS. 6B-6E, because the paddle frames 524 conform to theshape of the coaption element 510, the valve leaflets 20, 22 can becoapted completely around the coaption element by the paddle frames 524,including on the lateral and medial aspects 601, 603 of the coaptionelement 510. This coaption of the leaflets 20, 22 against the lateraland medial aspects of the coaption element 510 would seem to contradictthe statement above that the presence of a coaption element 510minimizes the distance the leaflets need to be approximated. However,the distance the leaflets 20, 22 need to be approximated is stillminimized if the coaption element 510 is placed precisely at aregurgitant gap and the regurgitant gap is less than the width(medial-lateral) of the coaption element 510.

Referring to FIGS. 6A and 6E, the coaption element 510 can take a widevariety of different shapes. In one exemplary embodiment, when viewedfrom the top (and/or sectional views from the top—See FIGS. 95-102), thecoaption element has an oval shape or an elliptical shape. The oval orelliptical shape can allow the paddle frames 524 co conform to the shapeof the coaption element and/or can reduce lateral leaks (See FIGS.65-83).

As mentioned above, the coaption element 510 can reduce tension of theopposing leaflets by reducing the distance the leaflets need to beapproximated to the coaption element 510 at the positions 601, 603. Thereduction of the distance of leaflet approximation at the positions 601,603 can result in the reduction of leaflet stresses and gradients. Inaddition, as is also explained above, the native valve leaflets 20, 22can surround or “hug” the coaption element in order to prevent lateralleaks. In one exemplary embodiment, the geometrical characteristics ofthe coaption element can be designed to preserve and augment these twocharacteristics of the device 500. Referring to FIG. 2A, as seen from anLeft Ventricular Outflow Tract (LVOT) view, the anatomy of the leaflets20, 22 is such that the inner sides of the leaflets coapt at the freeend portions and the leaflets 20, 22 start receding or spreading apartfrom each other. The leaflets 20, 22 spread apart in the atrialdirection, until each leaflet meets with the mitral annulus.

In one exemplary embodiment, the valve repair device 500 and itscoaption element 510 are designed to conform to the geometrical anatomyof the valve leaflets 20, 22. To achieve valve sealing, the valve repairdevice 500 can be designed to coapt the native leaflets to the coaptionelement, completely around the coaption element, including at the medial601 and lateral 603 positions of the copation element 510. Additionally,a reduction on forces required to bring the leaflets into contact withthe coaption element 510 at the positions 601, 603 can minimize leafletstress and gradients. FIG. 2B shows how a tapered or triangular shape ofa coaption element 510 will naturally adapt to the native valve geometryand to its expanding leaflet nature (toward the annulus).

FIG. 6D illustrates the geometry of the coaption element 510 and thepaddle frame 524 from an LVOT perspective. As can be seen in this view,the coaption element 510 has a tapered shape being smaller in dimensionin the area closer to where the inside surfaces of the leaflets 20, 22are required to coapt and increase in dimension as the coaption elementextends toward the atrium. The depicted native valve geometry isaccommodated by a tapered coaption element geometry. Still referring toFIG. 6D, the tapered coaption element geometry, in conjunction with theillustrated expanding paddle frame 524 shape (toward the valve annulus)can help to achieve coaptation on the lower end of the leaflets, reducestress, and minimize transvalvular gradients.

Referring to FIG. 6C, in one exemplary embodiment remaining shapes ofthe coaption element 510 and the paddle frames 524 can be defined basedon an Intra-Commissural view of the native valve and the device 510. Twofactors of these shapes are leaflet coaptation against the coaptionelement 510 and reduction of stress on the leaflets due to the coaption.Referring to FIGS. 6C and 67, to both coapt the valve leaflets 20, 22against the coaption element 510 and reduce the stress applied to thevalve leaflets 20, 22 by the coaption element 510 and/or the paddles524, the coaption element 510 can have a round or rounded shape and thepaddle frame 524 can have a full radius that spans from one leg of thepaddles to the other leg of the paddles. The round shape of the coaptionelement and/or the illustrated fully rounded shape of the paddle framewill distribute the stresses on the leaflets 20, 22 across a large,curved engagement area 607. For example, in FIG. 6C, the force on theleaflets 20, 22 by the paddle frames is spread along the entire roundedlength of the paddle frame 524, as the leaflets 20 try to open duringthe diastole cycle.

Referring to FIG. 67, in one exemplary embodiment, to cooperate with thefull rounded shape of the paddle frames 524, and/or in order to maximizeleaflet coaptation against the coaption element 510 andleaflet-to-leaflet coaptation at the sides 601, 603 of the coaptionelement 510, the shape of the coaption element in the intra-commissuralview follows a round shape. Referring to FIG. 67, the round shape of thecoaption element in this view substantially follows or is close to theshape of the paddle frames 524.

In one exemplary embodiment, the overall shape of the coaption element510 is an elliptical or oval cross section when seen from the surgeonsview (top view—See FIG. 70), a tapered shape or cross section when seenfrom an LVOT view (side view—See FIG. 69), and a substantially roundshape or rounded shape when seen from an intra-commissural view (SeeFIG. 68). In one exemplary embodiment, a blend of these three geometriescan result in the three dimensional shape of the illustrated coaptionelement 510 that achieves the benefits described above.

In one exemplary embodiment, the dimensions of the coaption element areselected to minimize the number of implants that a single patient willrequire (preferably one), while at the same time maintaining lowtransvalvular gradients. In one exemplary embodiment, theanterior-posterior distance X_(47B) at the top of the spacer is about 5mm, and the medial-lateral distance X_(67D) of the spacer at its widestis about 10 mm. In one exemplary embodiment, the overall geometry of thedevice 510 can be based on these two dimensions and the overall shapestrategy described above. It should be readily apparent that the use ofother anterior-posterior distance anterior-posterior distance X_(47B)and medial-lateral distance X_(67D) as starting points for the devicewill result in a device having different dimensions. Further, usingother dimensions and the shape strategy described above will also resultin a device having different dimensions.

Tables A, B, and C provide examples of values and ranges for dimensionsof the device and components of the device for some exemplaryembodiments. However, the device can have a wide variety of differentshapes and sizes and need not have all or any of the dimensional valuesor dimensional ranges provided in Tables A, B, and C. Table A providesexamples of linear dimensions X in millimeters and ranges of lineardimensions in millimeters for the device and components of the device.Table B provides examples of radius dimensions R in millimeters andranges of radius dimensions in millimeters for the device and componentsof the device. Table C provides examples of angular dimensions a indegrees and ranges of angular dimensions in degrees for the device andcomponents of the device. The subscripts for each of the dimensionsindicates the drawing in which the dimension first appears.

TABLE A Linear Dimensions (mm) Range A Range B Range C Range C Example(max) (min) (max) (min) (max) (min) (max) (min) X_(47A) 2.8 1.4 4.2 2.13.5 2.52 3.08 2.66 2.94 X_(47B) 5.3 2.65 7.95 3.975 6.625 4.77 5.835.035 5.565 X_(47C) 2.8 1.4 4.2 2.1 3.5 2.52 3.08 2.66 2.94 X_(47D) 3.31.65 4.95 2.475 4.125 2.97 3.63 3.135 3.465 X_(47E) 5.4 2.7 8.1 4.056.75 4.86 5.94 5.13 5.67 X_(47F) 8 4 12 6 10 7.2 8.8 7.6 8.4 X_(47G) 10.5 1.5 0.75 1.25 0.9 1.1 0.95 1.05 X_(52A) 12 6 18 9 15 10.8 13.2 11.412.6 X_(58A) 11 5.5 16.5 8.25 13.75 9.9 12.1 10.45 11.55 X_(59A) 27 13.540.5 20.25 33.75 24.3 29.7 25.65 28.35 X_(59B) 8 4 12 6 10 7.2 8.8 7.68.4 X_(59C) 7 3.5 10.5 5.25 8.75 6.3 7.7 6.65 7.35 X_(67A) 2.4 1.2 3.61.8 3 2.16 2.64 2.28 2.52 X_(67B) 3.7 1.85 5.55 2.775 4.625 3.33 4.073.515 3.885 X_(67C) 10 5 15 7.5 12.5 9 11 9.5 10.5 X_(67D) 10 5 15 7.512.5 9 11 9.5 10.5 X_(67E) 15 7.5 22.5 11.25 18.75 13.5 16.5 14.25 15.75X_(67F) 1 0.5 1.5 0.75 1.25 0.9 1.1 0.95 1.05 X₆₈ 14.2 7.1 21.3 10.6517.75 12.78 15.62 13.49 14.91 X_(70A) 1.7 0.85 2.55 1.275 2.125 1.531.87 1.615 1.785 X_(70B) 2.8 1.4 4.2 2.1 3.5 2.52 3.08 2.66 2.94 X_(71A)6.2 3.1 9.3 4.65 7.75 5.58 6.82 5.89 6.51 X_(71B) 5.4 2.7 8.1 4.05 6.754.86 5.94 5.13 5.67 X_(71C) 0.9 0.45 1.35 0.675 1.125 0.81 0.99 0.8550.945 X_(71D) 3.75 1.875 5.625 2.8125 4.6875 3.375 4.125 3.5625 3.9375X_(71E) 4.5 2.25 6.75 3.375 5.625 4.05 4.95 4.275 4.725 X_(72A) 10.4 5.215.6 7.8 13 9.36 11.44 9.88 10.92 X_(91A) 8.8 4.4 13.2 6.6 11 7.92 9.688.36 9.24 X_(91B) 7.8 3.9 11.7 5.85 9.75 7.02 8.58 7.41 8.19 X_(91C) 8.14.05 12.15 6.075 10.125 7.29 8.91 7.695 8.505 X_(91D) 13.6 6.8 20.4 10.217 12.24 14.96 12.92 14.28 X_(92A) 0.05 0.025 0.075 0.0375 0.0625 0.0450.055 0.0475 0.0525 X_(92B) 1.5 0.75 2.25 1.125 1.875 1.35 1.65 1.4251.575 X_(92C) 10.8 5.4 16.2 8.1 13.5 9.72 11.88 10.26 11.34 X_(95A) 13.86.9 20.7 10.35 17.25 12.42 15.18 13.11 14.49 X_(96A) 8.2 4.1 12.3 6.1510.25 7.38 9.02 7.79 8.61 X_(96B) 5.1 2.55 7.65 3.825 6.375 4.59 5.614.845 5.355 X_(96C) 0.5 0.25 0.75 0.375 0.625 0.45 0.55 0.475 0.525 X₉₇10.8 5.4 16.2 8.1 13.5 9.72 11.88 10.26 11.34 X_(98A) 9.8 4.9 14.7 7.3512.25 8.82 10.78 9.31 10.29 X_(98B) 5 2.5 7.5 3.75 6.25 4.5 5.5 4.755.25 X₉₉ 8 4 12 6 10 7.2 8.8 7.6 8.4 X_(100A) 9.7 4.85 14.55 7.27512.125 8.73 10.67 9.215 10.185 X_(100B) 4 2 6 3 5 3.6 4.4 3.8 4.2 X₁₀₁5.2 2.6 7.8 3.9 6.5 4.68 5.72 4.94 5.46 X_(102A) 8 4 12 6 10 7.2 8.8 7.68.4 X_(102B) 2.9 1.45 4.35 2.175 3.625 2.61 3.19 2.755 3.045 X_(117A)4.2 2.1 6.3 3.15 5.25 3.78 4.62 3.99 4.41 X_(117B) 14.5 7.25 21.7510.875 18.125 13.05 15.95 13.775 15.225 X_(117C) 13 6.5 19.5 9.75 16.2511.7 14.3 12.35 13.65

TABLE B Radius Dimensions (mm) Range A Range B Range C Range C Example(max) (min) (max) (min) (max) (min) (max) (min) R_(47A) 1.3 0.65 1.950.975 1.625 1.17 1.43 1.235 1.365 R_(47B) 1 0.5 1.5 0.75 1.25 0.9 1.10.95 1.05 R_(47C) 0.6 0.3 0.9 0.45 0.75 0.54 0.66 0.57 0.63 R_(47D) 52.5 7.5 3.75 6.25 4.5 5.5 4.75 5.25 R_(47E) 0.75 0.375 1.125 0.56250.9375 0.675 0.825 0.7125 0.7875 R_(67A) 0.75 0.375 1.125 0.5625 0.93750.675 0.825 0.7125 0.7875 R_(67B) 0.9 0.45 1.35 0.675 1.125 0.81 0.990.855 0.945 R_(70A) 1.4 0.7 2.1 1.05 1.75 1.26 1.54 1.33 1.47 R_(70B)0.4 0.2 0.6 0.3 0.5 0.36 0.44 0.38 0.42 R_(70C) 0.6 0.3 0.9 0.45 0.750.54 0.66 0.57 0.63 R_(70D) 7 3.5 10.5 5.25 8.75 6.3 7.7 6.65 7.35R_(71A) 1.6 0.8 2.4 1.2 2 1.44 1.76 1.52 1.68 R_(72A) 1.85 0.925 2.7751.3875 2.3125 1.665 2.035 1.7575 1.9425 R_(73A) 1.9 0.95 2.85 1.4252.375 1.71 2.09 1.805 1.995 R_(91A) 9.2 4.6 13.8 6.9 11.5 8.28 10.128.74 9.66 R_(91B) 0.3 0.15 0.45 0.225 0.375 0.27 0.33 0.285 0.315R_(91C) 0.3 0.15 0.45 0.225 0.375 0.27 0.33 0.285 0.315 R_(92A) 0.750.375 1.125 0.5625 0.9375 0.675 0.825 0.7125 0.7875 R_(94A) 1.65 0.8252.475 1.2375 2.0625 1.485 1.815 1.5675 1.7325 R_(96A) 1.7 0.85 2.551.275 2.125 1.53 1.87 1.615 1.785 R_(96B) 4.7 2.35 7.05 3.525 5.875 4.235.17 4.465 4.935 R_(98A) 1.3 0.65 1.95 0.975 1.625 1.17 1.43 1.235 1.365R_(98B) 7.6 3.8 11.4 5.7 9.5 6.84 8.36 7.22 7.98 R_(100A) 0.9 0.45 1.350.675 1.125 0.81 0.99 0.855 0.945 R_(100B) 9.6 4.8 14.4 7.2 12 8.6410.56 9.12 10.08 R_(102A) 0.45 0.225 0.675 0.3375 0.5625 0.405 0.4950.4275 0.4725 R_(102B) 8.5 4.25 12.75 6.375 10.625 7.65 9.35 8.075 8.925R_(115A) 9.3 4.65 13.95 6.975 11.625 8.37 10.23 8.835 9.765 R_(115B) 7.83.9 11.7 5.85 9.75 7.02 8.58 7.41 8.19 R_(115C) 7.8 3.9 11.7 5.85 9.757.02 8.58 7.41 8.19 R_(115D) 6.7 3.35 10.05 5.025 8.375 6.03 7.37 6.3657.035 R_(115E) 1.5 0.75 2.25 1.125 1.875 1.35 1.65 1.425 1.575

TABLE C Angular Dimensions (degrees) Exam- Range A Range B Range C RangeC ple (max) (min) (max) (min) (max) (min) (max) (min) α₄₇ 12 6 18 9 1510.8 13.2 11.4 12.6 α_(91A) 9 4.5 13.5 6.75 11.25 8.1 9.9 8.55 9.45α_(91B) 14 7 21 10.5 17.5 12.6 15.4 13.3 14.7 α_(91C) 20 10 30 15 25 1822 19 21 α_(117A) 39 19.5 58.5 29.25 48.75 35.1 42.9 37.05 40.95α_(117B) 3 1.5 4.5 2.25 3.75 2.7 3.3 2.85 3.15

Referring now to FIGS. 47-61, an implantable device 500 is shown invarious positions and configurations. The implantable device 500 caninclude any other features for an implantable prosthetic devicediscussed in the present application, and the device 500 can bepositioned to engage valve tissue 20, 22 as part of any suitable valverepair system (e.g., any valve repair system disclosed in the presentapplication).

The implantable device 500 has a proximal or attachment portion 505, acoaption element 510, inner anchor portions or inner paddles 522, outeranchor portions or outer paddles 520, anchor extension members or paddleframes 524, and a distal portion 507. The inner paddles 522 arejointably attached between the coaption element 510 and the outerpaddles 520. The outer paddles 520 are jointably attached between theinner paddles 522 and the distal portion 507. The paddle frames 524 areattached to the cap 514 at the distal portion 507 and extend to thejoint portion 523 between the inner and outer paddles 522, 520. In someembodiments, the paddle frames 524 are formed of a material that is morerigid and stiff than the material forming the paddles 522, 520 so thatthe paddle frames 524 provide support for the paddles 522, 520. In oneexemplary embodiment, the inner paddles 522 are stiff, relatively stiff,rigid, have rigid portions and/or are stiffened by a stiffening memberor the fixed portion of the clasps 530. The stiffening of the innerpaddle allows the device to move to the various different positionsshown and described herein. The inner paddle 522, the outer paddle 520,the coaption can all be interconnected as described herein, such thatthe device 500 is constrained to the movements and positions shown anddescribed herein.

Referring now to FIGS. 47-48, the device 500 is shown in a closedposition. When closed, the inner paddles 522 are disposed between theouter paddles 520 and the coaption element 510. In some embodiments, thedevice 500 includes clasps or gripping members 530 (FIG. 48) that can beopened and closed to grasp the native leaflets 20, 22 of the mitralvalve MV. The clasps 530 are attached to and move with the inner paddles522 and are disposed between the inner paddles 522 and the coaptionelement 510.

Referring now to FIGS. 49-51, the device 500 is shown in a partiallyopen position. The device 500 is moved into the partially open positionby an actuation wire or shaft 512 that passes through the attachmentportion 505 and coaption element 510 and can removably engage the distalportion 507. The actuation wire 512 is extended through the attachmentportion 505 such that a distance D between the attachment portion 505and distal portion 507 increases as the actuation wire 512 is extended.In the example illustrated by FIGS. 49-51, the pair of inner and outerpaddles 522, 520 are moved in unison, rather than independently, by asingle actuation wire 512. Also, the positions of the clasps 530 aredependent on the positions of the paddles 522, 520. For example,referring to FIG. 48 closing the paddles 522, 520 also closes theclasps. In one exemplary embodiment, the device 500 can be made to havethe paddles 520, 522 be independently controllable in the same manner asthe FIG. 11A embodiment.

Extending the actuation wire 512 pulls down on the bottom portions ofthe outer paddles 520 and paddle frames 524. The outer paddles 520 andpaddle frames 524 pull down on the inner paddles 522, where the innerpaddles 522 are connected to the outer paddles 520 and the paddle frames524. Because the attachment portion 505 and coaption element 510 areheld in place, the inner paddles 522 are caused to pivot in an openingdirection. The inner paddles 522, the outer paddles 520, and the paddleframes all flex to the position shown in FIG. 49. Opening the paddles522, 520 and frames 524 forms a gap 520A between the coaption element510 and the inner paddle 522 that can receive and grasp the nativeleaflets 20.

As is described above, some embodiments of the device 500 include claspsor gripping members 530. When the device 500 is partially opened theclasps 530 are exposed. In some embodiments, the closed clasps 530 (FIG.50) can be opened (FIG. 51), thereby creating a second opening or gap530A for receiving and capturing the native leaflets 20, 22. The extentof the gap 530A in the clasps 530 is limited to the extent that theinner paddle 522 has spread away from the coaption element 510.

Referring now to FIGS. 52-54, the device 500 is shown in a laterallyextended or open position. The device 500 is moved into the laterallyextended or open position by continuing to extend the actuation wire 512described above, thereby increasing the distance D between theattachment portion 505 and distal portion 507. Continuing to extend theactuation wire 512 pulls down on the outer paddles 520 and paddle frames524, thereby causing the inner paddles 522 to spread apart further fromthe coaption element 510. In the laterally extended or open position,the inner paddles 522 extend horizontally more than in other positionsof the device 500 and form an approximately 90-degree angle with thecoaption element 510. Similarly, the paddle frames 524 are at theirmaximum spread position when the device 500 is in the laterally extendedor open position. The increased gap 520A formed in the laterallyextended or open position allows clasps 530 to open further (FIG. 54)before engaging the coaption element 510, thereby increasing the size ofthe gap 530A.

Referring now to FIGS. 55-57, the device 500 is shown in athree-quarters extended position. The device 500 is moved into thethree-quarters extended position by continuing to extend the actuationwire 512 described above, thereby increasing the distance D between theattachment portion 505 and distal portion 507. Continuing to extend theactuation wire 512 pulls down on the outer paddles 520 and paddle frames524, thereby causing the inner paddles 522 to spread apart further fromthe coaption element 510. In the three-quarters extended position, theinner paddles 522 are open beyond 90 degrees to an approximately135-degree angle with the coaption element 510. The paddle frames 524are less spread than in the laterally extended or open position andbegin to move inward toward the actuation wire 512 as the actuation wire512 extends further. The outer paddles 520 also flex back toward theactuation wire 512. As with the laterally extended or open position, theincreased gap 520A formed in the laterally extended or open positionallows clasps 530 to open even further (FIG. 57), thereby increasing thesize of the gap 530A.

Referring now to FIG. 58, the device 500 is shown in an almost fullyextended position. The device 500 is moved into the almost fullyextended position by continuing to extend the actuation wire 512described above, thereby increasing the distance D between theattachment portion 505 and distal portion 507. Continuing to extend theactuation wire 512 pulls down on the outer paddles 520 and paddle frames524, thereby causing the inner paddles 522 to spread apart further fromthe coaption element 510. In the almost fully extended position theinner paddles 522 begin to approach an approximately 180-degree anglewith the coaption element 510. Although the inner paddles move to thisposition, the outer paddles 520 and the paddle frames 522 never move orflex to or past a ninety degree angle with respect to the coaptionelement 510. In the almost fully extended position the inner and outerpaddles 522, 520 can have a somewhat curved shape.

Referring now to FIGS. 59-61, the device 500 is shown in a fullyextended position. The device 500 is moved into the fully extendedposition by continuing to extend the actuation wire 512 described above,thereby increasing the distance D between the attachment portion 505 anddistal portion 507 to a maximum distance allowable by the device 500.Continuing to extend the actuation wire 512 pulls down on the outerpaddles 520 and paddle frames 524, thereby causing the inner paddles 522to spread apart further from the coaption element 510. The outer paddles520 and paddle frames 524 move to a position where they are close to theactuation wire. In the fully extended position, the inner paddles 522are open to an approximately 180-degree angle with the coaption element510. The inner and outer paddles 522, 520 are stretched straight in thefully extended position to form an approximately 180-degree anglebetween the paddles 522, 520. The fully extended position of the device500 provides the maximum size of the gap 520A between the paddles, and,in some embodiments, allows clasps 530 to also open fully toapproximately 180 degrees (FIG. 61) between portions of the clasp 530.The position of the device 500 is the narrowest configuration. Thus, thefully extended position of the device 500 may be a desirable positionfor bailout of the device 500 from an attempted implantation or may be adesired position for placement of the device in a delivery catheter, orthe like.

Referring now to FIGS. 62A-64C, an implantable device 700 is shown. Theimplantable device 700 has paddles 702 that open and close to graspleaflets 20, 22 against barbed clasps or gripping devices 704. Thepaddles 702 move to create an opening 706 between the paddles 702 andgripping devices 704 in which the leaflets 20, 22 can be grasped. Thedevice 700 can be configured to close a wide gap 26 (FIG. 6) in thenative heart valve MV, TV. In addition, the implantable device 700 caninclude any other features for a device discussed in the presentapplication, and the device 700 can be positioned to engage valveleaflets 20, 22 as part of any suitable valve repair system (e.g., anyvalve repair system disclosed in the present application). The device700 can include any other features for an implantable prosthetic devicediscussed in the present application, and the device 700 can bepositioned to engage valve tissue 20, 22 as part of any suitable valverepair system (e.g., any valve repair system disclosed in the presentapplication).

Referring to FIG. 62A, the paddles 702 of the device 700 are pivotedoutward in the direction X to create an opening 706 between the paddles702 and the gripping members 704 having a width W. The width W can be,for example, between about 5 mm and about 15 mm, such as between 7.5 mmand about 12.5 mm, such as about 10 mm. In alternative embodiments, thewidth W can be less than 5 mm or greater than 15 mm.

Referring to FIG. 62B, the paddles 702 of the device 700 are movedoutward in the direction Z such that the opening 706 has a width H. Thewidth H can be, for example, between about 10 mm and about 25 mm, suchas between about 10 mm and about 20 mm, such as between about 12.5 mmand about 17.5 mm, such as about 15 mm. In alternative embodiments, thewidth H can be less than 10 mm or more than 25 mm. In certainembodiments, the ratio between the width H and the width W can be about5 to 1 or less, such as about 4 to 1 or less such as about 3 to 1 orless, such as about 2 to 1 or less, such as about 1.5 to 1 or less, suchas about 1.25 to 1 or less, such as about 1 to 1. The device 700 can beconfigured such that the paddles 702 are pivoted outward in thedirection X and then moved outward in the direction Z to create theopening 706 having a width H between the paddles 702 and the grippingmembers 704. Alternatively, the device 700 can be configured such thatthe paddles are moved outward in the direction Z and then pivotedoutward in the direction X to create width H between the paddles 702 andgripping members 704. In addition, the device 700 can be configured suchthat the paddles 702 are pivoted outward in the direction X and movedoutward in the direction Z simultaneously to create the width H betweenthe paddles 702 and the gripping members 704.

FIGS. 63A-63C illustrate an implantable device 700 in which the paddles702 are pivoted outward in the direction X, and, subsequently, movedoutward in the direction Z to create a wider opening 706. FIG. 63Aillustrates the implantable device 700 in a closed position, such thatthe paddles 702 are engaging the gripping members 704. Referring to FIG.63B, the paddles 702 are pivoted outward in the direction X to create anopening 706 having a width W for receiving valve tissue. Referring toFIG. 63C, after the paddles 702 are pivoted outward in the direction X,the paddles 702 are moved outward in the direction Z such that theopening 706 has a width H. After valve tissue is received in theopenings 706 between the paddles 702 and the gripping members 704, thevalve repair device is moved back to the closed position (as shown inFIG. 63A) to secure the valve repair device 700 to the valve tissue. Theimplantable device 700 can include any other features for an implantabledevice discussed in the present application, and the implantable device700 can be positioned to engage valve tissue 20, 22 as part of anysuitable valve repair system (e.g., any valve repair system disclosed inthe present application).

FIGS. 64A-64C illustrate an implantable device 700 in which the paddles702 are moved outward in the direction Z, and, subsequently, pivotedoutward in the direction X to create a wider opening 706. FIG. 64Aillustrates the implantable device 700 in a closed position, such thatthe paddles 702 are engaging the gripping members 704. Referring to FIG.64B, the paddles 702 are moved outward in the direction Z to create anopening 706 having a width W for receiving valve tissue. Referring toFIG. 64C, after the paddles 702 are moved outward in the direction Z,the paddles 702 are pivoted outward in the direction X such that theopening 706 has a width H. After valve tissue is received in theopenings 706 between the paddles 702 and the gripping members 704, theimplantable device 700 is moved back to the closed position (as shown inFIG. 64A) to secure the implantable device 700 to the valve tissue. Theimplantable device 700 can include any other features for an implantabledevice discussed in the present application, and the implantable device700 can be positioned to engage valve tissue 20, 22 as part of anysuitable valve repair system (e.g., any valve repair system disclosed inthe present application).

While FIGS. 63A-63C illustrate a device 700 in which the paddles 702 arepivoted and then spread apart, and FIGS. 64A-64C illustrate a device 700in which the paddles 702 are spread apart and then pivoted, inalternative embodiments, a device 700 can include paddles 702 that canbe spread apart and pivoted simultaneously. In addition, in certainembodiments, the paddles 702 can be spread apart and pivotedindependently of each other. That is, in the embodiments for the valverepair device 700 shown in FIGS. 63A-63C and 64A-64C, as well as theembodiment in which the spreading apart and pivoting of each paddle 702is completed simultaneously, the paddles 702 can be controlledindependently of each other.

Referring now to FIGS. 65-83, the exemplary implantable device 500 isshown in the closed condition. Referring now to FIGS. 65-66, the device500 extends from a proximal portion 505 to a distal portion 507 andincludes a coaption portion 510, inner paddles 522, outer paddles 520,and paddle frames 524. In some embodiments, the outer paddles 520 extendto and/or around the paddle frames 524 and can have more than one layerto surround the paddle frames 524. The proximal portion 505 can includea collar 511 for attaching a delivery device (not shown). The distalportion 507 can include a cap 514 that is jointably attached to theouter paddles 520 and is engaged by an actuation wire (not shown) toopen and close the device 500 to facilitate implantation in the mitralvalve as described in the present application.

Referring now to FIGS. 67-68, a front view of the device 500 is shown.The device 500 has a shape that is substantially symmetrical around avertical front-to-back plane 550 and is generally narrower at the distalportion 507 than the proximal portion 505. The shape of the coaptionelement 510 and paddle frames 524 is generally rounded to prevent thedevice 500 from catching or snagging on structures of the heart, such asthe chordae tendineae, during implantation. For this reason, theproximal collar 511 (FIG. 68) and cap 514 (FIG. 68) also have roundedges. When viewed from the front or back, the paddle frames 524 can beseen to have a generally rounded shape, extending upwards and outwardsfrom the distal portion 507 to approximately coincide with the shape ofthe coaption element 510 when viewed from the front or back. Thus, thecoaption element 510 and paddle frames 524 generally define the shape ofthe device 500 when viewed from the front or back. In addition, therounded shape of the paddle frames 524 and the corresponding roundedshape of the coaption element can distribute leaflet stress across awider surface. In other exemplary embodiment, the paddle frames 524and/or the coaption element 510 can have other shapes.

Referring now to FIG. 69, a side view of the device 500 is shown. Aswith the front and back views (FIGS. 67-68), the device 500 has a shapethat is substantially symmetrical around a vertical side-to-side plane552 when viewed from the side. The distal portion 507 is also generallynarrower than the proximal portion 505 when the device 500 is viewedfrom the side. The coaption element 510 optionally also has a generallytapering shape that narrows toward the distal portion 507 of the device500. However, in other exemplary embodiments, the coaption element doesnot taper as it extends from the proximal portion of the device to thedistal portion of the device.

The generally rounded features of the device 500 are furtherdemonstrated by the round shape of the paddles 520, 522 where the innerand outer paddles 520, 522 are joined together and the round shape ofthe paddle frames 524. However, the paddles 520, 522 and paddle frames524 can take a wide variety of different forms. For example, the paddles520, 522 and the paddle frames 524 can be rounded along the top edges,but be flat or substantially flat on the sides of the paddles 520, 522and/or the paddle frames. By making the paddles 520, 522 flat orsubstantially flat on the sides, two devices can be implantedside-by-side on the mitral valve leaflet, with the two devices sittingsubstantially flush against each other.

The closed paddles 520, 522 form gaps 542 between the inner paddles 522and the coaption element 510 that are configured to receive nativetissue. As can be seen in FIG. 69, the narrowing of the coaption element510 gives the gaps 542 a somewhat teardrop shape that increases in widthas the gaps 542 approach the distal portion 507 of the device. Thewidening of the gaps 542 toward the distal portion 507 allows thepaddles 520, 522 to contact tissue grasped in the gaps 542 nearer to theproximal portion 505.

The paddle frames 524 extend vertically from the distal portion 507toward the proximal portion 505 until approximately a middle third ofthe device 500 before bending or flaring outward so that the connectionportion of the frames 524 passes through gaps 544 formed by the innerpaddles 522 folded inside of the outer paddles 520. However, in otherembodiments the connection of the frames are positioned inside the innerpaddles 522 or outside the outer paddles 520. The outer paddles 520 havea rounded shape that is similar to that of the coaption element 510 whenviewed from the front or back (FIGS. 67-68). Thus, the device 500 has asubstantially round shape. The round shape of the device 500 isparticularly visible when the device 500 is viewed from the top (FIGS.70-71) or bottom (FIGS. 72-73).

Referring now to FIGS. 70-71, top views of the device 500 are shown. Thedevice 500 has a shape that is substantially symmetrical around afront-to-back plane 550 and is also substantially symmetrical around aside-to-side plane 552 when viewed from the top. An opening 519A in thecoaption element 510 is visible at the proximal portion 505 of thedevice 500. As can be seen in FIG. 70, the coaption element 510 can behollow inside. The proximal collar 511 shown in FIG. 71 can be securedto the coaption element 510 to close off the coaption element 510.

In one exemplary embodiment, the coaption element is not planar and hasall curved surfaces. For example, the coaption elements 510 illustratedherein can be formed of a series of blended surfaces have a variety ofdifferent radii of curvature. The coaption element 510 has a generallyoval-shape when viewed from the top. However, in other exemplaryembodiments, the coaption element 510 can have other shapes when viewedfrom the top. For example, the coaption element can have a rectangular,square, diamond, elliptical, or any other shape. The paddle frames 224each have an arcuate shape with a smaller radius than the coaptionelement 510 so that the gaps 542 formed between the inner paddles 522and paddle frames 524 and the coaption element 510 taper as theyapproach left 551 and right 553 sides of the device 500. Thus, nativetissue, such as the leaflets 20, 22 tend to be pinched between thepaddle frames 524 and the coaption element 510 towards the left andright sides 551, 553 of the device 500.

Referring now to FIGS. 72-73, bottom views of the device 500 are shown.As with the top views (FIGS. 70-71), the device 500 has a shape that issubstantially symmetrical around the front-to-back plane 550 and is alsosubstantially symmetrical around the side-to-side plane 552 when viewedfrom the bottom. The cap 514 is shown in FIG. 73 and can jointablyattach to the outer paddles 520 and the paddle frames 524.

The paddle frames 524 extend outward from the distal portion 507 of thedevice 500 to the left and right sides 551, 553 at a narrow or slightangle from the side-to-side plane 552. The paddle frames 524 extendfurther away from the side-to-side plane 552 as the paddle frames 524extend toward the proximal portion of the device 500 (FIG. 69) toultimately form the arcuate shape seen in FIGS. 70-71.

Referring now to FIGS. 74-83, perspective and cross-sectional views ofthe device 500 are shown. Referring now to FIG. 74, the device 500 isshown sliced by cross-section plane 75 near the proximal portion of thecoaption element 510. Referring now to FIG. 75, a cross-sectional viewof the device 500 is shown as viewed from cross-section plane 75 in FIG.74. At the location of the plane 75, the coaption element 510 has agenerally round shape with lobes arranged along the front-to-back plane550. The gaps 542 between the paddle frames 524 and coaption element 510form a crescent-like shape with a central width 543. As noted above, thegaps 542 narrow as the gaps 542 approach the left and right sides 551,553.

Referring now to FIG. 76, the device 500 is shown sliced bycross-section plane 77 positioned about three-quarters of the waybetween the distal portion 507 and the proximal portion 505 of thecoaption element 510. Referring now to FIG. 77, a cross-sectional viewof the device 500 is shown as viewed from cross-section plane 77 in FIG.76. At the location of the plane 75, the coaption element 510 has agenerally oval shape oriented along the side-to-side plane 552. The gaps542 between the paddle frames 524 and coaption element 510 form acrescent-like shape with a central width 543 that is less than thecentral width 543 seen in FIG. 75. At the location of the plane 77, thewidth 543 of the gaps 542 is narrower towards the center of the device,widens somewhat as the gaps 542 approach the left and right sides 551,553 before narrowing again. Thus, the native tissue is pinched in thecenter of the gaps 542 about three-quarters of the way up the coaptionelement 510.

Referring now to FIG. 78, the device 500 is shown sliced bycross-section plane 79 positioned about half of the way between thedistal portion 507 and the proximal portion 505 of the coaption element510. Referring now to FIG. 79, a cross-sectional view of the device 500is shown as viewed from cross-section plane 79 in FIG. 78. At thelocation of the plane 79, the coaption element 510 has a generally ovalshape oriented along the side-to-side plane 552. The paddle frames 524can be seen near the left and right sides 551, 553 very close to or incontact with the coaption element 510. The gaps 542 are generallycrescent shaped and are wider than the gaps 542 viewed along the plane77 (FIG. 77.)

Referring now to FIG. 80, the device 500 is shown sliced bycross-section plane 81 positioned about one-quarter of the way betweenthe distal portion 507 and the proximal portion 505 of the coaptionelement 510. Referring now to FIG. 81, a cross-sectional view of thedevice 500 is shown as viewed from cross-section plane 81 in FIG. 80. Atthe location of the plane 81, the coaption element 510 has a generallyoval shape oriented along the side-to-side plane 552 that is narrowerthan the oval shape seen in FIG. 77. The paddle frames 524 can be seennear the left and right sides 551, 553 very close to or in contact withthe coaption element 510. The gaps 542 are generally crescent shaped andare wider than the gaps 542 viewed along the plane 79 (FIG. 79.)

Referring now to FIG. 82, the device 500 is shown sliced bycross-section plane 83 positioned near the distal portion 507 of thecoaption element 510. Referring now to FIG. 83, a cross-sectional viewof the device 500 is shown as viewed from cross-section plane 83 in FIG.82. At the location of the plane 83, the coaption element 510 has agenerally oval shape oriented along the side-to-side plane 552 that isnarrower than the oval shape seen in FIG. 79 as the coaption element 510tapers toward the distal portion 507 of the device 500. The paddleframes 524 can be seen near the left and right sides 551, 553 very closeto or in contact with the coaption element 510. While the inner paddles522 are not visible in FIG. 81, the gaps 542 are generally crescentshaped and are wider than the gaps 542 viewed along the plane 81 (FIG.81.)

Referring now to FIGS. 84-88, exemplary implantable devices 100, 500 areshown without clasps or articulable gripping members. Rather, theexemplary devices 100, 500 shown in FIGS. 84-88 have barbs or grippingmembers 800 and/or 802 integrated into portions of the coaption elementor paddles of the anchor portion of the devices to facilitate graspingof the tissue of the native heart valve.

Referring now to FIG. 84, an exemplary implantable device 100 is shownthat does not include articulable clasps or gripping elements. Asdescribed above, the device 100 is deployed from a delivery sheath 102and includes a coaption portion 104 and an anchor portion 106. Thecoaption portion 104 of the device 100 includes a coaption element 110that is adapted to be implanted between the leaflets 20, 22 of thenative mitral valve MV and is slidably attached to an actuation wire orshaft 112 that extends through the coaption element 110 to a distal cap114.

The anchor portion 106 of the device 100 includes outer paddles 120 andinner paddles 122 that are connected between the distal cap 114 and thecoaption element 110. The anchor portion 106 is actuatable between openand closed conditions and can take a wide variety of forms, such as, forexample, paddles, gripping elements, or the like. Actuation of theactuation wire 112 opens and closes the anchor portion 106 of the device100 to grasp the mitral valve leaflets 20, 22 during implantation.

Rather than articulable clasps or gripping elements, the device 100shown in FIG. 84 includes barbed portions 800 arranged on the coaptionelement 110, with each side of the coaption element 110 having at leastone barbed portion 800. When the anchor portion 106 of the device 100 isclosed, tissue grasped between the inner paddles 122 and the coaptionelement 110 is pressed against the barbed portions 800. The barbedportions 800 can be sharp so that they engage—and in some embodiments,pierce—the native tissue and prohibit the tissue from retracting fromthe device 100. In some embodiments, the barbed portions 800 are angleddownward to increase engagement with the native tissue.

Referring now to FIG. 85, the exemplary implantable device 100 is shownwithout separate articulable clasps. As described above, the device 100is deployed from a delivery sheath 102 and includes a coaption portion104 and an anchor portion 106. The coaption portion 104 of the device100 includes a coaption element 110 that is adapted to be implantedbetween the leaflets 20, 22 of the native mitral valve MV and isslidably attached to an actuation wire or shaft 112 that extends throughthe coaption element 110 to a distal cap 114.

The anchor portion 106 of the device 100 includes outer paddles 120 andinner paddles 122 that are connected between the distal cap 114 and thecoaption element 110. The anchor portion 106 is actuatable between openand closed conditions and can take a wide variety of forms, such as, forexample, paddles, gripping elements, or the like. Actuation of theactuation wire 112 opens and closes the anchor portion 106 of the device100 to grasp the mitral valve leaflets 20, 22 during implantation.

Rather than separate articulable clasps or gripping elements, the device100 shown in FIG. 85 includes barbed portions 800 arranged on the innerpaddles 122, with each inner paddle 122 having at least one barbedportion 800. When the anchor portion 106 of the device 100 is closed,tissue grasped between the inner paddles 122 and the coaption element110 is pressed against the barbed portions 800. The barbed portions 800are sharp so that they engage—and in some embodiments, pierce—the nativetissue and prohibit the tissue from retracting from the device 100. Insome embodiments, the barbed portions 800 are angled downward toincrease engagement with the native tissue.

Referring now to FIG. 86, the exemplary implantable device 500 is shownthat does not include articulable clasps or gripping elements. Asdescribed above, the device 500 includes a coaption portion 502 and ananchor portion 504. The coaption portion 502 of the device 500 includesa coaption element 510 that is adapted to be implanted between theleaflets 20, 22 of the native mitral valve MV and is slidably attachedto an actuation wire or shaft 512 that extends through the coaptionelement 510 to a distal cap 514.

The anchor portion 506 of the device 500 includes outer paddles 520 andinner paddles 522 that are connected between the distal cap 514 and thecoaption element 510. The anchor portion 506 is actuatable between openand closed conditions and can take a wide variety of forms, such as, forexample, paddles, gripping elements, or the like. Actuation of theactuation wire 512 opens and closes the anchor portion 506 of the device500 to grasp the mitral valve leaflets 20, 22 during implantation.

Rather than articulable clasps or gripping elements, the device 500includes barbed portions 800 arranged on the inner paddles 522, witheach inner paddle 522 optionally having more than one barbed portion800. When the anchor portion 506 of the device 500 is closed, tissuegrasped between the inner paddles 522 and the coaption element 510 ispressed against the barbed portions 800. The barbed portions 800 aresharp so that they engage—and in some embodiments, pierce—the nativetissue and prohibit the tissue from retracting from the device 500. Insome embodiments, the barbed portions 800 are angled downward toincrease engagement with the native tissue.

Referring now to FIG. 87, the exemplary implantable device 500 is shownthat does not include separate articulable clasps or gripping elements.As described above, the device 500 includes a coaption portion 502 andan anchor portion 504. The coaption portion 502 of the device 500includes a coaption element 510 that is adapted to be implanted betweenthe leaflets 20, 22 of the native mitral valve MV and is slidablyattached to an actuation wire or shaft 512 that extends through thecoaption element 510 to a distal cap 514.

The anchor portion 506 of the device 500 includes outer paddles 520 andinner paddles 522 that are connected between the distal cap 514 and thecoaption element 510. The anchor portion 506 is actuatable between openand closed conditions and can take a wide variety of forms, such as, forexample, paddles, gripping elements, or the like. Actuation of theactuation wire 512 opens and closes the anchor portion 506 of the device500 to grasp the mitral valve leaflets 20, 22 during implantation.

Rather than separate articulable clasps or gripping elements, the device500 includes barbed portions 800 arranged on the coaption element 510,with each side of the coaption element 510 having more than one barbedportion 800. When the anchor portion 506 of the device 500 is closed,tissue grasped between the inner paddles 522 and the coaption element510 is pressed against the barbed portions 800. The barbed portions 800are sharp so that they engage—and in some embodiments, pierce—the nativetissue and prohibit the tissue from retracting from the device 500. Insome embodiments, the barbed portions 800 are angled downward toincrease engagement with the native tissue.

Referring now to FIG. 88, the exemplary implantable device 500 is shownthat does not include separate articulable clasps or gripping elements.As described above, the device 500 includes a coaption portion 502 andan anchor portion 504. The coaption portion 502 of the device 500includes a coaption element 510 that is adapted to be implanted betweenthe leaflets 20, 22 of the native mitral valve MV and is slidablyattached to an actuation wire or shaft 512 that extends through thecoaption element 510 to a distal cap 514.

The anchor portion 506 of the device 500 includes outer paddles 520 andinner paddles 522 that are connected between the distal cap 514 and thecoaption element 510. The anchor portion 506 is actuatable between openand closed conditions and can take a wide variety of forms, such as, forexample, paddles, gripping elements, or the like. Actuation of theactuation wire 512 opens and closes the anchor portion 506 of the device500 to grasp the mitral valve leaflets 20, 22 during implantation.

Rather than articulable clasps or gripping elements, the device 500includes barbed portions 800 arranged on the coaption element 510, witheach side of the coaption element 510 including at least one barbedportion 800. Similar to device 1500 described above, the device 500 alsoincludes barbed portions 802 arranged on the inner paddles 522, witheach inner paddle 522 having at least one barbed portion 802.

When the anchor portion 506 of the device 500 is closed, tissue graspedbetween the inner paddles 522 and the coaption element 510 is pressedagainst the barbed portions 800, 802. The barbed portions 800, 802 aresharp so that they engage—and in some embodiments, pierce—the nativetissue and prohibit the tissue from retracting from the device 500. Insome embodiments, the barbed portions 800, 802 are angled downward toincrease engagement with the native tissue. The combination of barbedportions 800 on the coaption element 510 and barbed portions 802 on theinner paddles 522 forms the grasped tissue into an S-shaped tortuouspath as it passes over the barbed portions 800, 802. Thus, forcespulling the tissue away from the device 500 will encourage the tissue tofurther engage the barbed portions 800, 802 before the tissue canescape.

Referring now to FIGS. 89-102, the coaption element 510 and paddles 520,522 of the exemplary device 500 are shown. The coaption element 510 andthe paddles can be made from a wide variety of different materials. Thecoaption element 510 and paddles 520, 522 may be formed from a materialthat may be a metal fabric, such as a mesh, woven, braided, electrospunor formed in any other suitable way or a laser cut or otherwise cutflexible material. The material may be cloth, shape-memory alloywire—such as Nitinol—to provide shape setting capability, or any otherflexible material suitable for implantation in the human body.

In one exemplary embodiment, the coaption element is made from a braidedmesh of metal wires, such as a braided mesh of nitinol wires. In oneexemplary embodiment, the coaption element 510 is made of a braided meshof between 25 and 100 wires, such as between 40 and 85 wires, such asbetween 45 and 60 wires, such as about 48 Nitinol wires or 48 Nitinolwires.

The coaption element can be covered in a cloth, such as a polyethylenecloth. The coaption element 510 can be surrounded in its entirely with acloth cover, such as a polyethylene cloth of a fine mesh. The clothcover can provide a blood seal on the surface of the spacer, and/orpromote rapid tissue ingrowth.

The use of a shape memory material, such as braided Nitinol wire mesh,for the construction of the coaption element 510 results in a coaptionelement that can self-expandable, flexible in all directions, and/orresults in low strains when the coaption element is crimped and/or bent.The material can be a single piece, two halves joined together, or aplurality of sections or pieces that are fastened or joined together inany suitable manner, such as, by welding, with adhesives, or the like.

Referring now to FIGS. 89-90, the device 500 extends from a proximalportion 505 to a distal portion 507 and includes a coaption element 510,inner paddles 522, and outer paddles 520. The coaption element 510includes a proximal opening 519A and a distal opening 515 (FIGS. 92 and94). The proximal opening 519A of the coaption element 510 is formed ina proximal portion 519 of the coaption element 510. The coaption element510 is jointably connected to the inner paddles 522 by joint portions525. The inner paddles 522 are jointably connected to the outer paddles520 by joint portions 523. The outer paddles 520 are jointably attachedto distal portions 527 by joint portions 521. Coaption gaps 542 areformed between the inner paddles 522 and the coaption element 510.Paddle gaps 544 are formed between the inner and outer paddles 520, 522when the paddles 520, 522 are folded, for example, as shown in FIG. 90.

Referring now to FIG. 91, a front view of the device 500 is shown (aback view of which would be identical). The coaption element 510includes the proximal portion 519, a middle portion 518, and a distalportion 517. The proximal portion 519 includes the proximal opening519A. The distal portion 517 includes the distal opening 515 and isconnected to the joint portions 525. The shape of the coaption element510 is generally rounded to prevent the device 500 from catching orsnagging on structures of the heart, such as the chordae tendineae,during implantation.

Referring now to FIG. 92, a side view of the device 500 is shown.Similar to the device 500 viewed from the front, the distal portion 507of the device 500 is generally narrower than the proximal portion 505 ofthe device 500 when the device 500 is viewed from the side. The coaptionelement 510 flares outwards in the proximal portion 519 from theproximal opening 519A to the middle portion 518. The coaption element510 then tapers or narrows in the middle portion 518 from the proximalportion 519 to the distal portion 517. The distal portion 517 remainsnarrow and then splits into the two joint portions 525. The generallyrounded features of the device 500 are further demonstrated by the roundshape of the joint portions 523 that jointably connect the inner andouter paddles 520, 522 and the outwardly bowed shape of the outerpaddles 520.

The coaption gaps 542 formed between the inner paddles 522 and thecoaption element 510 are configured to receive native tissue. Thenarrowing of the coaption element 510 gives the gaps 542 a somewhatteardrop shape that increases in width as the gaps 542 approach thedistal portion 507 of the device 500. The widening of the gaps 542toward the distal portion 507 allows the inner paddles 522 to contacttissue grasped in the gaps 542 nearer to the proximal portion 505 wherepinching forces are greater as a result of the mechanical advantageprovided by the length of the paddles 520, 522 and other securing oranchoring elements, such as those described in the present application.

Referring now to FIG. 93, a top view of the device 500 is shown. Theproximal opening 519A in the coaption element 510 is visible at theproximal portion 505 of the device 500 and the coaption element 510 canbe seen to be hollow inside. The coaption element 510 has a generallyoval-shape when viewed from the top. While the paddles 520, 522 appearas protruding rectangular shapes, the paddles 520, 522 can extendlaterally and have an arcuate or crescent-like shape.

Referring now to FIG. 94, a bottom view of the device 500 is shown. Thedistal opening 515 in the coaption element 510 is visible at the distalportion 507 of the device 500 and the coaption element 510 can be seento be hollow inside. The coaption element 510 has a generally oval-shapewhen viewed from the top. While the paddles 520, 522 appear asprotruding rectangular shapes, the paddles 520, 522 can extend laterallyand have an arcuate or crescent-like shape. The distal portion 517 ofthe coaption element 510 can be seen splitting in two to join with thejoint portions 525.

Referring now to FIGS. 95-102, perspective and cross-sectional views ofthe device 500 are shown. Referring now to FIG. 95, the device 500 isshown sliced by cross-section plane 96 near the proximal portion of thecoaption element 510. Referring now to FIG. 96, a cross-sectional viewof the device 500 is shown as viewed from cross-section plane 96 in FIG.95. At the location of the plane 96, the coaption element 510 has agenerally oval shape with thicker portions along the sides of thecoaption element 510. The distal opening 515 is visible from theproximal portion and the coaption element 510 has a hollow interior.

Referring now to FIG. 97, the device 500 is shown sliced bycross-section plane 98 positioned about half of the way between thedistal portion 507 and the proximal portion 505 of the coaption element510. Referring now to FIG. 98, a cross-sectional view of the device 500is shown as viewed from cross-section plane 98 in FIG. 97. At thelocation of the plane 98, the coaption element 510 has a generally ovalshape that is larger than the oval shape of FIG. 96.

Referring now to FIG. 99, the device 500 is shown sliced bycross-section plane 100 positioned about one-quarter of the way betweenthe distal portion 507 and the proximal portion 505 of the coaptionelement 510. Referring now to FIG. 99, a cross-sectional view of thedevice 500 is shown as viewed from cross-section plane 100 in FIG. 99.At the location of the plane 100, the coaption element 510 has agenerally oval shape that is narrower than the oval shape seen in FIG.98.

Referring now to FIG. 101, the device 500 is shown sliced bycross-section plane 102 positioned near the distal portion 507 of thecoaption element 510. Referring now to FIG. 102, a cross-sectional viewof the device 500 is shown as viewed from cross-section plane 102 inFIG. 101. At the location of the plane 102, the coaption element 510 hasa generally oval shape that is smaller than the oval shape seen in FIG.100 and that is split as the coaption element 510 joins the jointportions 525.

Referring now to FIGS. 103-105, the exemplary implantable prostheticdevice 100 is shown having covered and uncovered portions. The device100 is shown implanted in the native mitral valve MV and secured to thenative leaflets 20, 22. As described above, the device 100 includes acoaption element 110, paddles 120, clasps 130, and a cap 114. Thepaddles 120 and clasps 130 are in a closed position to secure the device100 to the grasped native leaflets 20, 22 of the mitral valve MV. Aproximal portion 105 of the device 100 is exposed to the left atrium LAand a distal portion 107 of the device 100 is exposed to the leftventricle LV.

Referring now to FIG. 103, the device 100 is shown with a covering 900that covers the entirety of the coaption element 110 and the cap 114. Insome embodiments, the covering 900 can be a cloth or fabric such as PET,velour, electrospun or other suitable fabric. In other embodiments, inlieu of or in addition to a fabric, the cover can include a coating(e.g., polymeric) that is applied to the prosthetic spacer device and/ormechanical sealing mechanisms, such as silicone and interlocking jointscan be used. The covering 900 can be formed from a metal fabric, such asa mesh, woven, braided, or formed in any other suitable way or a lasercut or otherwise cut flexible material. The covering 900 may be cloth,shape-memory alloy wire—such as Nitinol—to provide shape settingcapability, or any other flexible material suitable for implantation inthe human body. The covering 900 prohibits blood flow through coaptionelement 110 at the proximal portion 105, and also provides a sealbetween the device 100 and the leaflets 20, 22. Thus, the covering 900aids in the prohibition of blood flow through the mitral valve MV at thelocation of the device 100. The covering 900 also prohibitsrecirculating blood flow from entering the device 100 from the distalportion 107.

Referring now to FIG. 104, the device 100 is shown with a covering 1000that partially covers the coaption element 110 from the proximal portion105 of the device 100 to the portion of the coaption element 110 thatengages the native leaflets 20, 22. In some embodiments, the cover canbe a cloth or fabric such as PET, velour, or other suitable fabric. Inother embodiments, in lieu of or in addition to a fabric, the cover caninclude a coating (e.g., polymeric) that is applied to the prostheticspacer device. The covering 1000 can be formed from a metal fabric, suchas a mesh, woven, braided, or formed in any other suitable way or alaser cut or otherwise cut flexible material. The covering 1000 may becloth, shape-memory alloy wire—such as Nitinol—to provide shape settingcapability, or any other flexible material suitable for implantation inthe human body. Thus, the covering 1000 prohibits blood flow through thecoaption element 110 at the proximal portion 105.

Referring now to FIG. 105, the device 100 is shown with a covering 1100that partially covers the coaption element 110 extending from theportion of the coaption element 110 that engages the native leaflets 20,22 toward the distal portion 107. The covering 1100 also covers the cap114. In some embodiments, the cover can be a cloth or fabric such asPET, velour, or other suitable fabric. In other embodiments, in lieu ofor in addition to a fabric, the cover can include a coating (e.g.,polymeric) that is applied to the prosthetic spacer device. The covering1100 can be formed from a mesh, woven, braided, or formed in any othersuitable way. The covering 1100 may be cloth, electrospun material,and/or shape-memory alloy wire—such as Nitinol—to provide shape settingcapability, or any other flexible material suitable for implantation inthe human body. Thus, blood flow can enter the coaption element 110 butis prohibited from passing through the device by the covering 1100arranged toward the distal portion 107. The covering 1100 also prohibitsrecirculating blood flow from entering the device 100 from the distalportion 107.

Referring now to FIGS. 106-109, an exemplary coaption element 1200 foran implantable prosthetic device is shown. The coaption element 1200 canbe used with any of the implantable prosthetic devices described in thepresent application. Referring to FIG. 106, the coaption element 1200has a generally cylindrical shape extending between two caps 1201.However, the coaption element 1200 can have any shape, such as any ofthe shapes disclosed herein. In one exemplary embodiment, the directionof expansion of the coaption element 1200 can be controlled. Forexample, the width/size of the coaption element in the Anterior toPosterior direction (when implanted), Medial to Lateral direction (whenimplanted), or both can be expanded (or contracted) in a controlledmanner. The coaption element can be made from a mesh 1200 of material.Referring now to FIG. 107, the mesh wall of the generally cylindricalcoaption element 1200 extends outward from the caps 1201 by a distance1204. Referring now to FIG. 108, axial forces 1208 are applied to thecaps 1201 of the coaption element 1200 causing the coaption element 1200to compress in an axial direction. Compressing the coaption element 1200axially causes the coaption element 1200 to expand or bulge in anoutward direction 1210, such that the distance 1204 increases.

The coaption element 1200 can be compressed in a wide variety ofdifferent ways. For example, a threaded connection can be used to drawthe two ends of the coaption element together or push the two ends ofthe coaption element apart. For example, a collar can be provided oneach end of the coaption element. One of the collars can threadedlyengage a threaded shaft, while the other collar is rotatably connectedto the shaft. Rotating the shaft in one direction draws the collarstogether. Rotating the shaft in the opposite direction moves the collarsapart.

Incorporating the coaption element 1200 into an implantable prostheticdevice of the present application allows the coaption element to beexpanded to press outward against tissue grasped between the coaptionelement and the paddles and/or gripping members.

Referring now to FIGS. 106A, 108A, 106B, and 108B, exemplary coaptionelements 1200, similar to the embodiment illustrated by FIGS. 106-109,for an implantable prosthetic device is shown. The coaption element 1200can be used with any of the implantable prosthetic devices described inthe present application. Referring to FIG. 106A, the coaption element1200 has a generally cylindrical shape extending between two caps 1201.However, the coaption element 1200 can have any shape, such as any ofthe shapes disclosed herein. In the example illustrated by FIGS. 106Aand 108A, the coaption element 1200 comprises a tube 1203 with slots1205. For example, the tube 1203 can be made from a shape memory alloy,such as nitinol, and the slots can be cut, such as laser cut, into thetube. The slots can be cut into the material that forms the tube, beforethe material is formed into a tube.

In one exemplary embodiment, the direction of expansion of the coaptionelement 1200 can be controlled. For example, the configuration of theslots 1205 and/or a shape-set of the tube can be selected to control theshape of the expanded coaption element 1200. For example, theconfiguration of the slots 1205 and/or a shape-set can determine the waythe width/size of the coaption element in the Anterior to Posteriordirection, and/or Medial to Lateral direction expanded (and/orcontract). Referring to FIG. 106A, the tube wall of the generallycylindrical coaption element 1200 can extend outward from caps 1201 by adistance 1204. Referring now to FIG. 108A, axial forces 1208 and/orrotational forces 1209 can be applied to the caps 1201 of the coaptionelement 1200 causing the coaption element 1200 to expand from theconfiguration illustrated by FIG. 106A to the configuration illustratedby FIG. 108A. In the illustrated example, compressing the coaptionelement 1200 axially and twisting the coaption element the coaptionelement 1200 to expand or bulge in an outward direction 1210, such thatthe distance 1204 increases.

Referring to FIGS. 106B and 108B, the coaption element 1200 can becompressed in a wide variety of different ways. For example, a threadedconnection 1221 can be used to draw the two ends of the coaption elementtogether and twist the coaption element in a first direction or push thetwo ends of the coaption element apart and twist the coaption element ina second direction. For example, a collar can be provided on each end ofthe coaption element. One of the collars can threadedly engage athreaded shaft, while the other collar is fixedly connected to theshaft. Rotating the shaft in one direction draws the collars togetherand rotates the collars relative to one another in a first direction.Rotating the shaft in the opposite direction moves the collars apart androtates the collars relative to one another in a second direction. Thepitch of the threaded connection can be selected to set a ratio betweenthe distance the coaption element 1200 is compressed and the angle thatthe coaption element is twisted.

Incorporating the coaption elements 1200 illustrated by FIGS. 106A,108A, 106B, and 108B into an implantable prosthetic device of thepresent application allows the coaption element to be expanded to pressoutward against tissue grasped between the coaption element and thepaddles and/or gripping members.

FIGS. 106C and 108C illustrate another exemplary embodiment of acontrollably expandable coaption element 1200 for an implantableprosthetic device. The coaption element 1200 can be used on its own,with a covering, or inside any of the coaption elements described herein(to expand the coaption element). The coaption element 1200 can be usedwith any of the implantable prosthetic devices described in the presentapplication. Referring to FIG. 106C, the coaption element 1200 has pairsof pivotally connected arms 1231. The pairs of pivotally connected arms1231 each extending between and pivotally connected to two caps 1201. Inthe illustrated example, there are two pairs of pivotally connected arms1231. However, there can be one, three, four, or any number of pairs ofpivotally connected arms.

In one exemplary embodiment, the direction of expansion of the coaptionelement 1200 can be controlled. For example, two pairs (as illustrated)of pivotally connected arms can be included to change the width/size ofthe coaption element in only one of the Anterior to Posterior direction,and/or Medial to Lateral direction. Four pairs of pivotally connectedarms 1231 can be included to change the width/size of the coaptionelement in both the Anterior to Posterior direction and Medial toLateral direction. When four pairs of pivotally connected arms 1231 areincluded, the arms may have different lengths and/or pivot pointlocations to make the coaption element 1200 expand (or contract)differently in different dictions. For example, the lengths of the armscan be selected to expand more in the Medial to Lateral direction thanthe Anterior to Posterior direction.

Referring now to FIG. 108C, axial forces 1208 can be applied to the caps1201 of the coaption element 1200 causing the coaption element 1200 toexpand from the configuration illustrated by FIG. 106C to theconfiguration illustrated by FIG. 108C. In the illustrated example,compressing the pivotally connected arms 1231 axially causes the pivotalconnections 1233 or knees to spread apart in an outward direction 1210,such that the distance 1204 increases.

Referring to FIGS. 106C and 108C, the coaption element 1200 can becompressed in a wide variety of different ways. For example, a threadedconnection 1221 can be used to draw the two ends of the coaption elementtogether or push the two ends of the coaption element apart. Forexample, a collar can be provided on each end of the coaption element.One of the collars can threadedly engage a threaded shaft, while theother collar is rotatably connected to the shaft. Rotating the shaft inone direction draws the collars together. Rotating the shaft in theopposite direction moves the collars apart.

Incorporating the coaption element 1200 illustrated by FIGS. 106C, and108C into an implantable prosthetic device of the present applicationallows the coaption element to be expanded to press outward againsttissue grasped between the coaption element and the paddles and/orgripping members.

FIGS. 106D and 108D illustrate another exemplary embodiment of anexpandable coaption element 1200 for an implantable prosthetic device.The coaption element 1200 can be used on its own, with a covering (SeeFIGS. 106E and 108E), or inside any of the coaption elements describedherein (to expand the coaption element). The coaption element 1200 canbe used with any of the implantable prosthetic devices described in thepresent application. Referring to FIG. 106C, the coaption element 1200has, a central support member 1243, one or more pivotally connected arms1241, and connection lines 1245. Each arm 1241 extends from a pivotalconnection to the central support member 1243. Each connection line 1245is connected to the central support member 1243 and a pivotallyconnected arm 1241. The length of the connection line 1245 sets thedegree to which the connection arms pivot away from the central supportmember 1243. In the illustrated example, there are two pivotallyconnected arms 1241. However, there can be one, three, four, or anynumber of pivotally connected arms.

In one exemplary embodiment, the direction of expansion of the coaptionelement 1200 can be controlled. For example, two pivotally connectedarms can be included to change the width/size of the coaption element inonly one of the Anterior to Posterior direction, and/or Medial toLateral direction. Four pivotally connected arms 1241 can be included tochange the width/size of the coaption element in both the Anterior toPosterior direction and Medial to Lateral direction. When four pivotallyconnected arms 1241 are included, the arms and/or the connection lines1245 may have different lengths and/or pivot point locations to make thecoaption element 1200 expand (or contract) differently in differentdictions. For example, the lengths of the arms and/or the connectionlines can be selected to expand more in the Medial to Lateral directionthan the Anterior to Posterior direction.

The arms 1241 can be moved from the contracted position (FIG. 106D) tothe expanded position (FIG. 108D). For example, the arms 1241 can bebiased toward the expanded position 1241 by a spring or other biasingmeans. In the illustrated example, restraints 1247, such as sutures holdthe arms 1241 in the contracted position. The restraints 1247 can beremoved or broken to cause the coaption element 1200 to expand from theconfiguration illustrated by FIG. 106D to the configuration illustratedby FIG. 108D.

FIGS. 106E and 108E illustrate an exemplary embodiment that is similarto the embodiment illustrated by FIGS. 106D and 108D, except that thecoaption element includes a covering material 1253. The coveringmaterial 1253 can extend from the central support member 1243 to eacharm 1241. The covering material 1253 can be used with the connectionlines 1245 or the covering material can eliminate the need for theconnection lines 1245.

Referring now to FIG. 106F, an exemplary coaption element 1200, similarto the embodiment illustrated by FIGS. 106-109, for an implantableprosthetic device is shown. The coaption element 1200 can be used withany of the implantable prosthetic devices described in the presentapplication. Referring to FIG. 106F, the coaption element 1200 isdefined by a coil 1263 extending between two caps 1201. The coaptionelement 1200 can have any shape, such as any of the shapes disclosedherein. The coil 1263 can be made from a shape memory alloy, such asnitinol.

In one exemplary embodiment, the direction of expansion of the coaptionelement 1200 can be controlled. For example, the shape-set of the coil1263 can be selected to control the shape of the expanded coaptionelement 1200. For example, the configuration of the shape-set candetermine the way the width/size of the coaption element in the Anteriorto Posterior direction, and/or Medial to Lateral direction expand(and/or contract). Referring to Axial forces 1208 and/or rotationalforces 1209 can be applied to caps 1201 of the coaption element 1200causing the coaption element 1200 to expand or retract from theconfiguration illustrated by FIG. 106F. In the illustrated example,extending the coil 1263 axially and twisting the coil 1263 contracts thecoil in an inward direction 1211 and compressing the coil 1263 axiallyand twisting the coil in the opposite direction expands or bulge thecoil in an outward direction.

Referring to FIG. 106F, the coaption element 1200 can be compressed in awide variety of different ways. For example, a threaded connection 1221can be used to draw the two ends of the coaption element together andtwist the coaption element in a first direction or push the two ends ofthe coaption element apart and twist the coaption element in a seconddirection. For example, a collar can be fixedly connected to each end ofthe coil 1263. One of the collars can threadedly engage a threadedshaft, while the other collar is fixedly connected to the shaft.Rotating the shaft in one direction draws the collars together androtates the collars relative to one another in a first direction.Rotating the shaft in the opposite direction moves the collars apart androtates the collars relative to one another in a second direction. Thepitch of the threaded connection can be selected to set a ratio betweenthe distance the coaption element 1200 is compressed and the angle thatthe coaption element is twisted.

Incorporating the coaption elements 1200 illustrated by FIG. 106F intoan implantable prosthetic device of the present application allows thecoaption element to be expanded to press outward against tissue graspedbetween the coaption element and the paddles and/or gripping members.

FIGS. 106G-106I illustrate exemplary embodiments of expandable coaptionelements 1200. In the examples illustrated by FIGS. 106G-106I, thecoaption elements are inflated by a fluid medium to expand the coaptionelement. The fluid medium can take a wide variety of different forms.Examples of fluids that can be used to inflate the coaption element 1200include, but are not limited to, air, gel, water, blood, foamingmaterials, etc. The coaption element 1200 can be used with any of theimplantable prosthetic devices described in the present application.

Referring to FIG. 106G, the coaption element 1200 can have an outerlayer 1271 (For example, any of the coaption elements 110, 510 disclosedherein) and an inner layer 1273 or balloon. The coaption element 1200can have any shape, such as any of the shapes disclosed herein. In theexample illustrated by FIGS. 106G and 1086, the inner layer 1273 isdisposed in the outer layer 1271 and can have generally the same shapeas the inner surface of the outer layer. The inner layer can be madefrom an expandable material, such as a rubber or other materialtraditionally used for making balloons and angioplasty devices. Theouter layer 1271 can be made from a shape memory alloy, such as nitinol.

Referring to FIGS. 106H and 106I, in one exemplary embodiment, thedirection of expansion of the coaption element 1200 can be controlled.In the example illustrated by FIG. 106H, the inner layer 1273 comprisestwo balloons that are optionally connected together. However, any numberof balloons can be used. For example, the inner layer can comprise 3, 4,or any number of balloons. The balloons can be individually inflated tocontrol the shape of expansion of the coaption element 1200. When theballoons are connected together, the connection can also affect theshape of expansion. In the example illustrated by 106H, the balloons areconnected together along a plane 1275 or area. Expansion of the innerlayer 1273 in the direction 1277 will be less than the expansion in thedirection 1279 due to the connection 1275. As such, in this example, theexpansion due to inflation can be limited to or substantially limited toexpansion in the Medial to Lateral direction.

The use of multiple balloons and the configuration of any connectionsbetween the balloons can determine the way the width/size of thecoaption element in the Anterior to Posterior direction, and/or Medialto Lateral direction expand (and/or contract).

In the example illustrated by FIG. 106I, the inner layer 1273 comprisesone or more supports 1281 or struts. One support 1281 is illustrated,but any number can be used. For example, the inner layer can comprise 2,3, 4, or any number of supports. The supports 1281 can divide the innerlayer into multiple independently inflatable chambers or the supportsmay not seal off independent chambers and inflation fluid applied to anychamber will fill all of the chambers. When there are independentlyinflatable chambers, the chambers can be individually inflated tocontrol the shape of expansion of the coaption element 1200. Thesupports also affect the shape of expansion. In the example illustratedby 106I, the support 1281 will reduce or eliminate expansion of theinner layer 1273 in the direction 1277. As such, in this example, theexpansion due to inflation can be limited to or substantially limited toexpansion in the Medial to Lateral direction.

The use of multiple independently inflatable chambers and/or theconfiguration of the support members 1281 can determine the way thewidth/size of the coaption element in the Anterior to Posteriordirection, and/or Medial to Lateral direction expand (and/or contract).

Incorporating the coaption elements 1200 illustrated by FIGS. 106G-106Iinto an implantable prosthetic device of the present application allowsthe coaption element to be expanded to press outward against tissuegrasped between the coaption element and the paddles and/or grippingmembers.

Referring now to FIGS. 110-111, an exemplary implantable prostheticdevice 1300 is shown. The device 1300 is similar to the device 100,described above, and includes a coaption element 1310, paddles 1320, andclasps or gripping members 1330. Referring now to FIG. 111, a top viewof the coaption element 1310 is shown. As can be seen in FIG. 111, thecoaption element 1310 has a generally oval-shaped cross-section. Thecoaption element 1310 does not include a central opening and can beformed from a solid piece of material, such as foam. Forming thecoaption element 1310 from a solid piece of foam material prohibitsblood from flowing through the center of the coaption element 1310,thereby substantially eliminating a location where blood can becaptured. The device 1300 can include any other features for animplantable prosthetic device discussed in the present application, andthe device 1300 can be positioned to engage valve tissue 20, 22 as partof any suitable valve repair system (e.g., any valve repair systemdisclosed in the present application). The prosthetic device 1300 can beopened and closed in a wide variety of different ways. For example, asleeve can be slidably disposed over the coaption element to engage andopen the paddles. Or, the paddles can be opened by pulling a line orsuture that opens the clasps and the movement of the clasps can open thepaddles. However, any mechanism for opening and closing the device 1300can be used.

Referring now to FIGS. 112-128, an exemplary paddle frame 1400 for animplantable prosthetic device is shown. The paddle frame 1400 can beused with any of the implantable prosthetic devices described in thepresent application. The paddle frame 1400 is formed from a piece ofmaterial 1402, such as nitinol, or any other suitable material. Thepaddle frame 1400 extends from a cap attachment portion 1410 to a paddleconnection portion 1420 and has a proximal portion 1422, a middleportion 1424, and a distal portion 1426. In some embodiments, the paddleframe 1400 includes attachment portions 1440 for securing a cover (seeFIG. 30), the inner paddle 520, and/or the outer paddle 522 to thepaddle frame 1400. In some embodiments, the paddle frame 1400 is thinnerin the location of the fifth curve 1438 to facilitate bending of bothsides of the paddle frame 1400 toward the center plane 1404 during, forexample, crimping of the device.

The paddle frame 1400 extends between a first attachment portion 1412 ina generally rounded, three-dimensional shape through the proximal,middle, and distal portions 1422, 1424, 1426 and returns to a secondattachment portion 1414. To form a rounded three-dimensional shape, thepaddle frame 1400 is bent or curved in multiple locations as the paddleframe 1400 extends between the first and second attachment portions1412, 1414. The attachment portions 1412, 1414 include notches 1416,1418 respectively for attachment to the cap. The paddle frame 1400flexes at the area 1419. The area 1419 can include a wider portion 1417to distribute the stress that results from flexing the paddle frame 1400over a greater area. Also, notches 1416, 1418 can include radiusednotches 1415 at each end of the notches. The radiused notches 1415 serveas strain reliefs for the bending area 1419 and the area where thepaddle frame 1400 connects to the cap.

Referring to FIG. 191, in another exemplary embodiment, a flat blank1403 of paddle frame 1400 can be cut, for example laser cut, from a flatsheet of material. Referring to FIG. 192, the cut blank 1403 can then bebent to form the three-dimensional shaped paddle frame 1400.

Referring to FIGS. 193 and 194, in one exemplary embodiment, the paddleframes 1400 can be shape set to provide increased clamping force againstor toward the coaption element 510 when the paddles 520, 522 are in theclosed configuration. This is because the paddle frames are shape-setrelative to the closed position (e.g. FIG. 194) to a first position(e.g., FIG. 193) which is beyond the position where the inner paddle 520would engage the coaption element, such as beyond the central plane 552of the device 500, such as beyond the opposite side of the coaptionelement, such as beyond the outer paddle on the opposite side of thecoaption element. Referring to FIG. 194, the paddle frame 194 is flexedand attached to the inner and outer paddles 522, 520, for example bystitching. This results in the paddle frames having a preload (i.e., theclamping force against or toward the coaption element is greater thanzero) when the paddle frames 1400 are in the closed configuration. Thus,shape-setting the paddle frames 1400 in the FIG. 193 configuration canincrease the clamping force of the paddle frames 1400 compared to paddleframes that are shape-set in the closed configuration (FIG. 194).

The magnitude of the preload of the paddle frames 1400 can be altered byadjusting the degree to which the paddle frames 1400 are shape-setrelative to the coaption element 510. The farther the paddle frames 1400are shape set past the closed position, the greater the preload.

The curves of the paddle frame 1400 may be independent from one another,that is, one curve is complete before another curve starts, or may becombined, that is, the paddle frame 1400 curves in multiple directionssimultaneously.

The paddle frame 1400 curves away from a median or central plane 1404(FIG. 115) at a first curve 1430 to widen the shape of the paddle frame1400. As can be seen in FIG. 117, the paddle frame 1400 also curves awayfrom a frontal plane 1406 in the location of the first curve 1430. Thepaddle frame 1400 curves away from the outward direction of the firstcurve 1430 at a second curve 1432 to form sides of the frame 1400. Thepaddle frame continues to slope away from the frontal plane 1406 in thelocation of the second curve 1432. In some embodiments, the second curve1432 has a larger radius than the first curve 1430. The paddle frame1400 curves away from the frontal plane 1406 at a third curve 1434 asthe paddle frame 1400 continues to curve in the arc of the second curve1432 when viewed from the frontal plane 1406. This curvature at thethird curve 1434 results in a gradual departure of the frame 1400, andthus the native valve leaflet from the centerline 1406. This departurefrom the centerline results in spreading of the leaflet tissue towardthe valve annulus, which can result in less stress on the leaflettissue. The paddle frame 1400 curves toward the lateral plane 1404 at afourth curve 1436 as the frame 1400 continues to curve away from thefrontal plane 1406. The rounded three-dimensional shape of the paddleframe 1400 is closed with a fifth curve 1438 that joins both sides ofthe paddle frame 1400. As can be seen in FIGS. 116 and 118, the paddleframe 1400 has a generally arcuate shape as the frame 1400 extends awayfrom the attachment portion 1420 and to the closed portion 1424. Themiddle portion 1422 of the frame is closer to the frontal plane 1406than the closed portion 1424, giving the sides of the middle portion1422 a rounded, wing-like shape that engages the curved surface ofcoaption element (not shown) during grasping of native tissue between apaddle (not shown) and coaption element of an implantable device of thepresent invention.

Referring now to FIGS. 119-120, the paddle frame 1400 is shown in anexpanded condition (FIG. 119) and a compressed condition (FIG. 120). Thepaddle frame 1400 is in a compressed condition when the paddles aredisposed in a delivery device 1450. Referring to FIG. 119, the paddleframe 1400 is moved from the expanded condition to the compressedcondition by compressing the paddle in the direction X and extending alength of the paddle in the direction Y. When the paddles 1400 are inthe compressed condition, the paddles have a width H. The width H canbe, for example between about 4 mm and about 7 mm, such as, betweenabout 5 mm and about 6 mm. In alternative embodiments, the width H canbe less than 4 mm or more than 7 mm. In certain embodiments, the width Hof the compressed paddles 1400 is substantially equal to a width D ofthe delivery opening 1452 of the delivery device 1450. The ratio betweenthe width W of the paddles in the expanded condition and the width H ofthe paddles in the compressed condition can be, for example, about 4 to1 or less, such as about 3 to 1 or less, such as about 2 to 1 or less,such as about 1.5 to 1, such as about 1.25 to 1, such as about 1 to 1.In alternative embodiments, the ratio between the width W and the widthH can be more than 4 to 1. FIG. 120 illustrates the connection portions1410 compressed from the positions illustrated by FIG. 119. However, insome exemplary embodiments, the connection portions 1410 will not becompressed. For example, the connection portions 1410 will not becompressed when the connection portions 1410 are connected to a cap 514.

Referring now to FIGS. 121-124, the exemplary implantable device 500 isshown in open and closed conditions with paddle frames that arecompressed or stretched as the anchor portion 506 of the device isopened and closed. The paddle frames 1524 are like the paddle frame 1400described above. Referring now to FIG. 121, the anchor portion 506 isshown in a closed condition. Referring now to FIG. 122, the paddleframes 1524 have a first width W1 and a first length L1. Referring nowto FIG. 123, the anchor portion 506 is shown in an open condition andthe paddle frames 1524 are in an extended condition (FIG. 124). Openingthe anchor portion 506 of the device 500 causes the paddle frames 1524to pivot outward from the coaption portion 510 and transition to theextended condition. In the extended condition, the paddle frames 1524have a second or extended length L2 and a second or extended width W2.In the extended condition, the paddle frame 1524 lengthens and narrowssuch that the second length L2 is greater than the first length L1 andthe second width W2 is narrower than the first width W1. One advantageof this embodiment is that the paddle frames become narrower and canhave less chordal engagement during grasping of the leaflets. However,the paddle frames become wide when the implant is closed to enhancesupport of the leaflet. Another advantage of this embodiment is that thepaddle frames also become narrower and longer in the bailout position.The narrower paddle size in the elongated or bailout position can allowfor less chordal entanglement and increased ease of bailout.

Referring now to FIGS. 125-128, the exemplary implantable device 500 isshown in open and closed conditions with paddle frames that arecompressed or stretched as the anchor portion 506 of the device isopened and closed. The paddle frames 1624 are similar to the paddleframe 1400 described above. Referring now to FIG. 125, the anchorportion 506 is shown in a closed condition. Referring now to FIG. 126,the paddle frames 1624 have a first width W1 and a first length L1.Referring now to FIG. 127, the anchor portion 506 is shown in an opencondition and the paddle frames 1624 are in a compressed condition (FIG.128). Opening the anchor portion 506 of the device 500 causes the paddleframes 1624 to pivot outward from the coaption portion 510 andtransition to the compressed condition. In the compressed condition, thepaddle frames 1624 have a second or compressed length L2 and a second orcompressed width W2. In the compressed condition, the paddle frame 1624shortens and widens such that the second length L2 is less than thefirst length L1 and the second width W2 is wider than the first widthW1.

Referring now to FIGS. 129-136, exemplary implantable prosthetic devicesare shown that can be locked or fastened closed. Referring now to FIG.129, the exemplary implantable prosthetic device 500 is shown that canbe locked or retained in a closed condition with magnets. As describedabove, the device 500 includes a coaption element 510 and paddles 520.The paddles 520 open and close to grasp leaflets 20, 22 of the nativeheart valve, as described in more detail above. The coaption element 510includes one or more magnets 1700 and the paddles 520 include one ormore magnets 1702. The magnets 1700, 1702 have opposite poles facingeach other such that the magnets 1702 in the paddles 520 are attractedto the magnets 1700 in the coaption element 510 and the magneticattractive forces between the magnets 1700, 1702 retain the paddles 520in a closed condition. In certain embodiments, the magnets 1700, 1702are programmed or polymagnets with patterns of polarity such that theimplantable device 500 can be locked and unlocked by moving—such asrotating—the magnet 1700 within the coaption element. For example, themagnet 1700 can be configured such that the magnet 1700 attracts themagnets 1702 in the paddles 520 in a first orientation and repels themagnets 1702 in the paddles 520 when the magnet 1700 is rotated 90degrees into a second orientation.

Referring now to FIGS. 130-131, the exemplary implantable prostheticdevice 500 is shown that can be locked or retained in a closed conditionwith an elastic band 1800. The elastic band 1800 can be made from anyflexible material and have any configuration. For example, the elasticband can comprise coiled nitinol, can have a stent like structure, etc.

As described above, the device 500 includes a coaption element 510,paddles 520, and barbed clasps 530. The paddles 520 and barbed clasps530 open and close to grasp leaflets 20, 22 of the native heart valve,as described in more detail above. The paddles 520 move between an opencondition (FIG. 130) to a closed condition (FIG. 131) by actuation of anactuation wire or shaft 512, as described above. The elastic band 1800can be arranged to lock or retain the device 500 in a closed condition.When the device 500 is in the open condition (FIG. 130) the band 1800 isarranged around the paddles 520 in a relaxed or disengaged condition.For example, the band 1800 may be arranged around a narrower portion ofthe open device 500, such as a tapered portion of the paddles 520 near adistal portion 507 of the device. When the device 500 is in the closedcondition (FIG. 131) the band 1800 is arranged around the paddles 520 inan engaged condition. In certain embodiments, when the band 1800 is inthe engaged condition it is arranged around the widest portion of thedevice 500 or can be arranged around the center of the device 500.

The band 1800 is moved from the disengaged condition in a closing orengaging direction 1802 to the engaged condition with sutures (notshown) or other suitable means of moving the band 1800. Movement of theband 1800 can cause the paddles 520 to move in a closing direction 1804,thereby closing and securing the device 500 in a single movement of theband 1800. Alternatively, device 500 may be closed and the band 1800moved into the engaged location to secure the device 500 in the closedcondition.

Referring now to FIG. 132, the exemplary implantable prosthetic device500 is shown that can be locked or retained in a closed condition with abiasing member 1900. As described above, the device 500 includes acoaption element 510, paddles 520, and barbed clasps 530. The paddles520 are moved between open and closed positions with an actuation wire512 extending through the coaption element 510 to a cap 514. The paddles520 and barbed clasps 530 are opened and closed to grasp leaflets 20, 22of the native heart valve, as described in more detail above. In theclosed condition, the paddles 520 and the clasps 530 engage the tissueof valve leaflets 20, 22 and each other to secure the device 500 to thevalve tissue.

The biasing member 1900 (e.g., a spring) is configured to bias the cap514 toward the coaption element 510, thereby biasing the device 500toward the closed condition. After the device 500 is delivered to andattached to the valve tissue with a delivery device (not shown), thedelivery device is removed from the patient's body and the biasingmember 1900 maintains the device 500 in a closed condition to preventdetachment of the device 500 from the valve tissue.

Referring now to FIGS. 133-134, an exemplary implantable prostheticdevice 2000 is shown that can be locked or retained in a closedcondition with latches. The device 2000 can include any other featuresfor an implantable prosthetic device discussed in the presentapplication, and the device 2000 can be positioned to engage valvetissue 20, 22 as part of any suitable valve repair system (e.g., anyvalve repair system disclosed in the present application).

The device 2000 is similar to other implantable devices described aboveand includes paddles 2002 and gripping members or clasps 2004. Thepaddles 2002 are opened and closed to grasp the native leaflets 20, 22in a gap 2006 between the paddles 2002 and gripping members 2004. Thedevice 2000 also includes a latch member 2008 attached to the paddles2002, in which the latch member 2008 is configured to attach the paddles2002 to the gripping members 2004 when the device 2000 is in the closedposition. In some embodiments, the latch member 2008 serves as asecondary latching mechanism and is configured to keep the device 2000in the closed position when other mechanisms fail.

Referring to FIG. 133, the device 2000 is in an open position with valvetissue 20, 22 disposed in the gap or opening 2006 between the paddles2002 and the gripping members 2004. Referring to FIG. 134, the device2000 is moved to the closed position such that the valve tissue 20, 22is secured between the paddles 2002 and the gripping members 2004. Thedevice 2000 can be moved to the closed position by any suitable manner,such as, for example, any manner described in the present application.When the device 2000 is moved to the closed position, the latch member2008 punctures the valve tissue 20, 22 and is inserted into or throughthe gripping member 2004 to secure the paddle 2002 to the grippingmember 2004. The latch member 2008 can take any suitable form that cansecure the paddles 2002 to the gripping members 2004, such as, forexample, metals, plastics, etc.

Referring now to FIGS. 135-136, the exemplary implantable prostheticdevice 2000 is shown that can be locked or retained in a closedcondition with latches. In FIGS. 135-136, the device 2000 includes acoaption element 2010. Referring to FIG. 135, the device 2000 is in anopen position with valve tissue 20, 22 disposed in the gap or opening2006 between the paddles 2002 and the gripping members 2004. Referringto FIG. 136, the device 2000 is moved to the closed position such thatthe valve tissue 20, 22 is secured between the paddles 2002 and thegripping members 2004. The device 2000 can be moved to the closedposition by any suitable manner, such as, for example, any mannerdescribed in the present application. When the device 2000 is moved tothe closed position, the latch member 2008 punctures the valve tissue20, 22 and is inserted into or through the gripping member 2004 tosecure the paddle 2002 to the gripping member 2004. In the illustratedembodiment, the latch member 2008 protrudes beyond the gripping members2004 and into the coaption element 2010. In some embodiments, the latchmember 2008 may be secured in the coaption element 2010 by latching ontoa portion of the coaption element 2010 or by penetrating the coaptionelement 2010 material. The latch member 2008 can take any suitable formthat can secure the paddles 2002 to the gripping members 2004, such as,for example, metals, plastics, etc.

Referring now to FIGS. 137-145, various embodiments of implantableprosthetic devices and methods of using the same are shown thatfacilitate release of native tissue grasped by the implantableprosthetic devices. The devices can include any other features for animplantable prosthetic device discussed in the present application, andthe devices can be positioned to engage valve tissue 20, 22 as part ofany suitable valve repair system (e.g., any valve repair systemdisclosed in the present application).

Referring now to FIG. 137, a device 2100 with stretchable clasps orgripping members is shown. The device 2100 is delivered from a deliverysheath 2102 and has a coaption element 2110, paddles 2120, and clasps orgripping members 2130. The gripping members 2130 include barbs 2132 andstretchable portions 2134. The stretchable portions 2134 allow theclasps 2130 to be stretched in a stretching direction 2136. Actuationsutures 2104 extend from the delivery sheath 2102 to the clasps 2130.Retracting the sutures 2104 in a retraction direction 2106 opens andstretches the clasps 2130 to a fully extended position. In certainembodiments, the clasps 2130 primarily stretch once the clasps 2130 arein the fully open position. Movement of the barbs 2132 in the stretchingdirection 2136 allows for clean disengagement from the native tissue. Insome embodiments, the stretchable portion 2134 is configured to be movedsuch that the barbs 2132 exit the valve tissue in a directionsubstantially opposite the direction in which the barbs entered thenative tissue. Alternatively, the clasps 2130 can be otherwiseextendable to allow for disengagement from the native tissue withouttearing the native tissue. For example, joint portions 2131 can beconfigured to allow the barbs 2132 of the clasps 2130 to be pulled inthe direction 2136.

Referring now to FIGS. 138-143, two exemplary embodiments of methods ofreleasing valve tissue from the prosthetic device 500 are shown. Asdescribed above, the device 500 includes a coaption element 510, innerpaddles 522, outer paddles 520, and barbed clasps 530. The device 500 isdeployed from a delivery sheath 502. An actuation wire 512 extendsthrough the coaption element 510 to a cap 514. Actuation of theactuation wire 512 opens and closes the paddles 520, 522 to open andclose the device. The barbed clasps 530 include barbs 536, moveable arms534, and stationary arms 532. The stationary arms 532 are attached tothe inner paddles 522 so that the clasps 530 move with the movement ofthe inner paddles 522. Actuation sutures 537 extend from the deliverysheath 502 to the moveable arms 534 of the clasps 530.

FIGS. 138-141 illustrate an exemplary method of releasing grasped valvetissue. In the example illustrated by FIGS. 138-141, the device is shownin a substantially open position to more clearly illustrate themovements of the parts of the device 500 that are involved with tissuerelease. However, in practice the tissue release method is more likelyto be practiced with the device 500 in the more closed positionsillustrated by FIGS. 142 and 143. That is, it is not likely that thepaddles and clasps will be substantially opened before moving the claspsto release the valve tissue as illustrated by FIGS. 138-141. It is morelikely that the paddles and clasps will only be opened slightly beforereleasing the valve tissue as illustrated by FIGS. 142 and 143. The sameparts that move in the example illustrated by FIGS. 138-141 move in theexample illustrated by FIGS. 142-143.

Referring now to FIG. 138, the device 500 is shown in a substantiallyopen position with the clasps 530 in a closed position. Retraction ofthe actuation sutures 537 pivots the moveable arms 534 of the clasps 530to a partially open position (FIG. 139) and then to a fully openposition (FIG. 140). Referring now to FIG. 141, once the clasps 530 arein the fully open position (FIG. 140), further retraction of theactuation sutures 537 in the retraction direction 560 pulls upward onthe moveable arms 534, barbs 536, and inner paddles 522 in a tissuerelease direction. The portion 523 of the inner paddles 522 closest tothe coaption element flex upward in direction 562 to allow this movementin the retraction direction 560. There can optionally be a small gapG₁₄₀ between the claps 530 and the coaption element 510. The innerpaddles can flex at the small gap (if there is a small gap) or at theconnection 523 between the coaption element 510 and the inner paddles ifthere is not a gap. This flexing movement 562 of the inner paddles 522can optionally also cause the outer paddles to pivot downward. Movementof the barbs 536 in the tissue release direction 560 allows for cleandisengagement from the native tissue. The barbs can be at an angle θ(see FIG. 138) to the moveable arms 534 that facilitates release fromthe tissue. For example, the angle θ can be between 10 and 60 degrees,such as 20 and 50 degrees, such as 25 and 45 degrees, such as about 30degrees, or 30 degrees.

Referring now to FIGS. 142-143, the device 500 is shown in a slightlyopened position or a closed position. As mentioned above, the same partsof the device 500 move in the example illustrated by FIGS. 142 and 143as in the example illustrated by FIGS. 138-141. In the partially openposition or closed position, further retraction of the actuation sutures537 in the retraction direction 560 pulls upward on the moveable arms534, barbs 536, and inner paddles 522. The portion of the inner paddles522 closest to the coaption element flexes or is lifted-up in thedirection 562 to allow the movement 560. As mentioned above, there canoptionally be a small gap G₁₄₀ between the clasps 530 and the coaptionelement 510. The inner paddles can flex 562 at the small gap (if thereis a small gap) or at the connection between the coaption element 510and the inner paddles if there is not a gap. The movement of the barbs536 in the direction 560 releases the valve tissue from the barbs. Thelifting on the inner paddles 522 can optionally also force the outerpaddles 520 to move outward in an opening direction 564. The optionaloutward movement 564 of the outer paddles 520 relieves the pinchingforce applied to grasped tissue by the paddles and the coaption element.Relieving the pinching force on the tissue can also assist in therelease of the tissue from the barbs. In one exemplary embodiment, thedevice 500 is moved from the position illustrated by FIG. 143 to theposition illustrated by FIG. 140 or 141 to fully disengage the devicefrom the native valve.

FIGS. 144-152 show an exemplary delivery assembly 2200 and itscomponents. Referring to FIG. 144, the delivery assembly 2200 cancomprise the implantable prosthetic spacer device 500 (or any otherimplantable device described in the present application) and a deliveryapparatus 2202. The delivery apparatus 2202 can comprise a plurality ofcatheters and catheter stabilizers. For example, in the illustratedembodiment, the delivery apparatus 2202 includes a first catheter 2204,a second catheter 2206, a third catheter 2208, and catheter stabilizers2210. The second catheter 2206 extends coaxially through the firstcatheter 2204, and the third catheter 2208 extends coaxially through thefirst and second catheters 2204, 2206. The prosthetic spacer device 500can be releasably coupled to a distal end portion of the third catheter2208 of the delivery apparatus 2202, as further described below.

In the illustrated embodiment, the delivery assembly 2200 is configured,for example, for implanting the prosthetic spacer device 500 in a nativemitral valve via a transseptal delivery approach. In other embodiments,the delivery assembly 2200 can be configured for implanting theprosthetic spacer device 500 in aortic, tricuspid, or pulmonary valveregions of a human heart. Also, the delivery assembly 2200 can beconfigured for various delivery methods, including transseptal,transaortic, transventricular, etc.

Referring to FIG. 146, the first collar or cap 514 of the prostheticspacer device 500 can include a bore 516A. In some embodiments, the bore516A can comprise internal threads configured to releasably engagecorresponding external threads on a distal end 512B of the actuationshaft 512 of the delivery apparatus 2202, as shown in FIG. 145.

Referring again to FIG. 146, the second or proximal collar 511 of theprosthetic spacer device 500 can include a central opening 511C that isaxially aligned with the bore 516A of the cap 514. The central opening511C of the proximal collar 511 can be configured to slidably receivethe actuation shaft 512 of the delivery apparatus 2202, as shown in FIG.145. In some embodiments, the proximal collar 511 and/or the coaptionelement 510 can have a sealing member (not shown, but see, e.g., thesealing member 413 shown in FIG. 23) configured to seal the centralopening 511C when the actuation shaft 512 is withdrawn from the centralopening 511C.

As shown in FIG. 146, the proximal collar 511 can also include aplurality of bosses or projections 511A and a plurality of guideopenings 511B. The projections 511A can extending radially outwardly andcan be circumferentially offset (e.g., by about 90 degrees) relative tothe guide openings 511B. The guide openings 511B can be disposedradially outwardly from the central opening 511C. The projections 511Aand the guide openings 511B of the proximal collar 511 can be configuredto releasably engage a coupler 2214 of the delivery apparatus 2202, asshown in FIG. 145.

Referring again to FIG. 144 and as mentioned above, the deliveryapparatus 2202 can include the first and second catheters 2204, 2206.The first and second catheters 2204, 2206 can be used, for example, toaccess an implantation location (e.g., a native mitral valve region of aheart) and/or to position the third catheter 2208 at the implantationlocation.

The first and second catheters 2204, 2206 can comprise first and secondsheaths 2216, 2218, respectively. The catheters 2204, 2206 can beconfigured such that the sheaths 2216, 2218 are steerable. Additionaldetails regarding the first catheter 2204 can be found, for example, inU.S. Published Patent Application No. 2016/0155987, which isincorporated by reference herein in its entirety. Additional detailsregarding the second catheter 2206 can be found, for example, in U.S.Provisional Patent Application No. 62/418,528, which is incorporated byreference herein in its entirety.

Referring still to FIG. 144, delivery apparatus 2202 can also includethe third catheter 2208, as mentioned above. The third catheter 2208 canbe used, for example, to deliver, manipulate, position, and/or deploythe prosthetic spacer device 500 at the implantation location.

Referring to FIG. 148, the third catheter 2208 can comprise theactuation or inner shaft 512, the coupler 2214, an outer shaft 2220, ahandle 2222 (shown schematically), and clasp control members 537. Aproximal end portion 2220 a of the outer shaft 2220 can be coupled toand extend distally from the handle 2222, and a distal end portion 2220b of the outer shaft 2220 can be coupled to the coupler 2214. A proximalend portion 512A of the actuation shaft 512 can coupled to an actuationknob 2226. The actuation shaft 512 can extend distally from the knob2226 (shown schematically), through the handle 2222, through the outershaft 2220, and through the coupler 2214. The actuation shaft 512 can bemoveable (e.g., axially and/or rotationally) relative to the outer shaft2220 and the handle 2222. The clasp control members 537 can extendthrough and be axially movable relative to the handle 2222 and the outershaft 2220. The clasp control members 537 can also be axially movablerelative to the actuation shaft 512.

As shown in FIGS. 145-146, the actuation shaft 512 of the third catheter2208 can be releasably coupled to the cap 514 of the prosthetic spacerdevice 500. For example, in some embodiments, the distal end portion512B of the actuation shaft 512 can comprise external thread configuredto releasably engage the interior threads of the bore 516A of theprosthetic spacer device 500. As such, rotating the actuation shaft 512in a first direction (e.g., clockwise) relative to the cap 514 of theprosthetic spacer device 500 releasably secures the actuation shaft 512to the cap 514. Rotating the actuation shaft 512 in a second direction(e.g., counterclockwise) relative to the cap 514 of the prostheticspacer device 500 releases the actuation shaft 512 from the cap 514.

Referring now to FIGS. 145-147, the coupler 2214 of the third catheter2208 can be releasably coupled to the proximal collar 511 of theprosthetic spacer device 500. For example, in some embodiments, thecoupler 2214 can comprise a plurality of flexible arms 2228 and aplurality of stabilizer members 2230. The flexible arms 2228 cancomprise apertures 2232, ports 2233 (FIG. 146), and eyelets 2234 (FIG.147). The flexible arms 2228 can be configured to pivot between a firstor release configuration (FIG. 146) and a second or coupledconfiguration (FIGS. 145 and 147). In the first configuration, theflexible arms 2228 extend radially outwardly relative to the stabilizermembers 2230. In the second configuration, the flexible arms 2230 extendaxially parallel to the stabilizer members 2230 and the eyelets 2234radially overlap 2234, as shown in FIG. 147. The flexible arms 2228 canbe configured (e.g., shape-set) to be biased to the first configuration.

The prosthetic spacer device 500 can be releasably coupled to thecoupler 2214 by inserting the stabilizer members 2230 of the coupler2214 into the guide openings 511B of the prosthetic spacer device 500.The flexible arms 2228 of the coupler 2214 can then be pivoted radiallyinwardly from the first configuration to the second configuration suchthat the projections 511A of the prosthetic spacer device 500 extendradially into the apertures 2232 of the flexible arms 2228. The flexiblearms 2228 can be retained in the second configuration by inserting thedistal end portion 512B of the actuation shaft 512 through openings 2236of the eyelets 2234, which prevents the flexible arms 2228 from pivotingradially outwardly from the second configuration to the firstconfiguration, thereby releasably coupling the prosthetic spacer device500 to the coupler 2214.

The prosthetic spacer device 500 can be released from the coupler 2214by proximally retracting the actuation shaft 512 relative to the coupler2214 such that the distal end portion 512B of the actuation shaft 512withdraws from the openings 2236 of the eyelets 2234. This allows theflexible arms 2228 to pivot radially outwardly from the secondconfiguration to the first configuration, which withdraws theprojections 511A of the prosthetic spacer device 500 from the apertures2232 of the flexible arms 2228. The stabilizer members 2230 can remaininserted into the guide openings 511B of the prosthetic spacer device500 during and after the flexible arms 2228 are released. This can, forexample, prevent the prosthetic spacer device 500 from moving (e.g.,shifting and/or rocking) while the flexible arms 2228 are released. Thestabilizer members 2230 can then be withdrawn from the guide openings511B of the prosthetic spacer device 500 by proximally retracting thecoupler 2214 relative to the prosthetic spacer device 500, therebyreleasing the prosthetic spacer device 500 from the coupler 2214.

Referring to FIG. 148, the outer shaft 2220 of the third catheter 2208can be an elongate shaft extending axially between the proximal endportion 2220 a, which is coupled the handle 2222, and the distal endportion 2220 b, which is coupled to the coupler 2214. The outer shaft2220 can also include an intermediate portion 2220 c disposed betweenthe proximal and distal end portions 2220 a, 2220 b.

Referring to FIG. 149, the outer shaft 2220 can comprise a plurality ofaxially extending lumens, including an actuation shaft lumen 2238 and aplurality of control member lumens 2240 (e.g., four in the illustratedembodiment). In some embodiments, the outer shaft 2220 can comprise more(e.g., six) or less (e.g., two) than four control member lumens 2240.

The actuation shaft lumen 2238 can be configured to receive theactuation shaft 512, and the control member lumens 2240 can beconfigured to receive one or more clasp control members 537. The lumens2238, 2240 can also be configured such that the actuation shaft 512 andclasp control members 537 can be movable axially and/or rotationally)relative to the respective lumens 2238, 2240. In particular embodiments,the lumens 2238, 2240 can comprise a liner or coating configured toreduce friction within the lumens 2238, 2240. For example, the lumens2238, 2240 can comprise a liner comprising PTFE.

Referring still to FIGS. 148-149, the outer shaft 2220 can be formedfrom various materials, including metals and polymers. For example, inone particular embodiment, the proximal end portion 2220 a can comprisestainless steel and the distal and intermediate portions 2220 b, 2220 ccan comprise PEBAX (e.g., PEBAX®). The outer shaft 2220 can alsocomprise an outer covering or coating, such as a polymer that isreflowed over the portions 2220 a, 2220 b, and 2220 c.

The outer shaft 2220 can include one or more coil portions 2242 disposedradially outwardly from the lumens 2238, 2240. For example, in oneparticular embodiment, the outer shaft 2220 can comprise a first coil2242 a, a second coil 2242 b, and a third coil 2242 c. The first coil2242 a can be the radially outermost coil, the third coil 2242 c can bethe radially innermost coil, and the second coil 2242 b can be radiallydisposed between the first coil 2242 a and the third coil 2242 c.

The coil portions 2242 can comprise various materials and/orconfigurations. For example, the coil portions 2242 can be formed fromstainless steel. In one particular embodiment, the first and third coils2242 a, 2242 c comprise stainless steel coils wound in a left handconfiguration, and the second coil 2242 b comprises a stainless steelcoil wound in a right hand configuration.

The coil portions 2242 can also comprise various pitches. The pitch ofone or more of the coils 2242 can be the same or different than thepitch of one or more other coils 2242. In one particular embodiment, thefirst and second coils 2242 a, 2242 b can have a first pitch (e.g., 0.74in.), and the third coil can comprise a second pitch (e.g., 0.14 in.).

The outer shaft 2220 can also comprise a tie layer 2244 disposedradially inwardly from the third coil 2242 c. The tie layer 2244 can beformed of various materials including polymers, such as PEBAX (e.g.,PEBAX®).

As shown in FIGS. 150-152, the handle 2222 of the third catheter 2208can include a housing 2246, an actuation lock mechanism 2248, a claspcontrol mechanism 2250, and a flushing mechanism 2252. Referring to FIG.150, a distal end portion of the housing 2246 can be coupled to theproximal end portion 2220 a of the outer shaft 2220. The actuation lockmechanism 2248, the clasp control mechanism 2250, and a flushingmechanism 2252 can be coupled to a proximal end of the housing 2246. Theactuation lock mechanism 2248 can be configured to selectively lock theposition of the actuation shaft 512 relative to the housing 2246 and theouter shaft 2220. The clasp control mechanism 2250 can also be coupledto proximal end portions of the clasp control members 537 and can beconfigured to secure the clasp control members 537 relative to thehandle 2222 and to move the clasp control members 537 relative to theouter shaft 2220 and the actuation shaft 512. The flushing mechanism2252 can be configured for flushing (e.g., with a saline solution) theouter shaft 2220 prior to inserting the outer shaft 2220 into apatient's vasculature.

As shown in FIGS. 151-152, the housing 2246 of the handle 2222 cancomprise a main body 2254 and a nose portion 2256 coupled to a distalend portion of the main body 2254. The main body 2254 and the noseportion 2256 can be coupled together in various manners, includingfasteners 2258 and/or pins 2260 (e.g., as shown in the illustratedembodiment), adhesive, and/or other coupling means. The housing 2246 canbe formed from various materials, including polymers (e.g.,polycarbonate).

The main body 2254 of the housing 2246 can comprise a plurality oflumens, including an actuation shaft lumen 2262, control member lumens2264 (FIG. 152), and a flushing lumen 2266 that connects with theactuation shaft lumen 2262 (FIG. 151). As shown in FIG. 152, the mainbody 2254 can also include a plurality of tubes (e.g., hypotubes),including an actuation tube 2268 and control member tubes 2270 that aredisposed at least partially in the actuation shaft lumen 2262 and thecontrol member lumens 2264, respectively. The tubes 2268, 2270 can beaxially movable (e.g., slidable) relative the lumens 2262, 2264,respectively.

The proximal end of the actuation tube 2268 can extend proximally fromthe main body 2256 and can be coupled to the knob 2226 and to theproximal end portion 512A of the actuation shaft 512. The proximal endsof the control member tubes 2270 can extend proximally from the mainbody 2254 and can be coupled to the clasp control mechanism 2250 and theclasp control members 537.

The distal ends of the tubes 2268, 2270 can comprise flanges 2272, 2274configured to engage a stopper to limit the axial movement of the tubes2268, 2270 relative to the housing 2224. For example, the flanges 2272,2274 can be configured to contact respective surfaces of the main body2254 (e.g., a lip) to prevent to tubes 2268, 2270 from withdrawingcompletely from the proximal ends of the lumens 2262, 2264,respectively.

The actuation tube 2268 can be configured to receive and be coupled tothe proximal end portion of the actuation shaft 512. The control membertubes 2270 can be configured to receive portions of the clasp controlmechanism 2250, as further described below. The tubes 2268, 2270 can beformed from various materials, including polymers and metals (e.g.,stainless steel).

In some embodiments, the main body 2254 can include a plurality of sealmembers 2276 (e.g., O-rings) configured to prevent or reduce bloodleakage through the lumens and around the shafts and/or tubes. The sealmembers can be secured relative to the main body 2254, for example, byfasteners 2278 (e.g., hollow-lock or socket-jam set screws).

As shown in FIG. 152, the nose portion 2256 of the housing 2246 cancomprise a plurality of lumens, including an actuation shaft lumen 2280and control member lumens 2282. The actuation shaft lumen 2280 of thenose portion 2256 can be extend coaxially with the actuation shaft lumen2262 of the main body 2254. Proximal ends of the control member lumens2282 of the nose portion 2256 can be aligned with the control memberlumens 2264 of the main body 2254 at the proximal end of the noseportion 2256 (i.e., the lumens 2282, 2264 are in the same plane). Thecontrol member lumens 2282 can extend from the proximal ends at an angle(i.e., relative to the control member lumens 2264 of the main body2254), and distal ends of the control member lumens 2282 can connectwith the actuation shaft lumen 2280 of the nose portion 2256 at alocation toward the distal end of the nose portion 2256. In other words,the proximal ends of the lumens 2282 are in a first plane (i.e., theplane of the control member lumens 2264 of the main body 2254), and thedistal ends of the lumens 2282 are in a second plane (i.e., the plane ofthe actuation shaft lumen 2262 of the main body 2254).

As shown in FIG. 151, the actuation shaft lumen 2280 of the nose portion2256 can be configured to receive the proximal end portion of the outershaft 2220. The proximal end portion of the outer shaft 2220 can becoupled to the nose portion 2256 in many ways such as with adhesive,fasteners, frictional fit, and/or other coupling means.

Referring still to FIG. 151, the actuation lock mechanism 2248 of thehandle 2222 can be coupled to the proximal end portion of the main body2254 of the housing 2246 and to the actuation tube 2268. The actuationlock mechanism 2248 can be configured to selectively control relativemovement between the actuation tube 2268 and the housing 2246. This, inturn, selectively controls relative movement between the actuation shaft512 (which is coupled to the actuation tube 2268) and the outer shaft2220 (which is coupled to the nose portion 2256 of the housing 2246).

In some embodiments, the actuation lock mechanism 2248 can comprise alock configuration, which prevents relative movement between theactuation tube 2268 and the housing 2246, and a release configuration,which allows relative movement between the actuation tube 2268 and thehousing 2246. In some embodiments, the actuation lock mechanism 2248 canbe configured to include one or more intermediate configurations (i.e.,in addition to the lock and release configuration) which allow relativemovement between the actuation tube 2268 and the housing 2246, but theforce required to cause the relative movement is greater than when theactuation lock mechanism is in the release configuration.

As shown in FIG. 151 of the illustrated embodiment, the actuation lockmechanism 2248 can comprise a lock (e.g., a Tuohy-Borst adapter) 2284and a coupler (e.g., a female luer coupler) 2286. The coupler 2286 canbe attached to the distal end of the lock 2284 and coupled to theproximal end of the main body 2254 of the housing 2246. The actuationtube 2268 can coaxially extend through the lock 2284 and the coupler2286. As such, rotating a knob 2288 of the lock 2284 in a firstdirection (e.g., clockwise) can increase the frictional engagement ofthe lock 2284 on the actuation tube 2268, thus making relative movementbetween the actuation tube 2268 and the housing 2246 more difficult orpreventing it altogether. Rotating a knob 2288 of the lock 2284 in asecond direction (e.g., counterclockwise) can decrease the frictionalengagement of the lock 2284 on the actuation tube 2268, thus makingrelative movement between the actuation tube 2268 and the housing 2246easier.

In other embodiments, actuation lock mechanism 2248 can comprise otherconfigurations configured for preventing relative movement between theactuation tube 2268 and the housing 2246. For example, the lockingmechanism 2248 can include lock configured like a stopcock valve inwhich a plunger portion of valve selectively engages the actuation tube2268.

The clasp control mechanism 2250 can comprise an actuator member 2290and one or more locking members 2292 (e.g., two in the illustratedembodiment). A distal end portion of the actuator member 2290 can becoupled to the control member tubes 2270, which extend from the proximalend of the main body 2254 of the housing 2246, as best shown in FIG.151. The locking members 2292 can be coupled to a proximal end portionof the actuator member 2290.

As shown in the illustrated embodiment, the actuator member 2290 can,optionally, comprise a first side portion 2294 and a second side portion2296 selectively coupled to the first side portion 2294 by a connectingpin 2298. The actuator member 2290 can be configured such that the firstand second side portions 2294, 2296 move together when the connectingpin 2298 is inserted through the first and second side portions 2294,2296. When the connecting pin 2298 is withdrawn, the first and secondside portions 2294, 2296 can be moved relative to each other. This canallow the clasp control members 537 (which are releasably coupled to thefirst and second side portions 2294, 2296 by the locking elements 2292)to be individually actuated.

The connection between the first and second side portions 2294, 2296 canbe configured such that the first and second side portions 2294, 2296can move axially (i.e., proximally and distally) but not rotationallyrelative to each other when the connecting pin 2298 is withdrawn. Thiscan be accomplished, for example, by configuring the first side portion2294 with keyed slot or groove and configuring second side portion 2296with a keyed projection or tongue that corresponds to the keyed slot orgroove of the first side portion 2294. This can, for example, prevent orreduce the likelihood that the clasp control members 537 from twistingrelative to the outer shaft 2220.

The first and second side portions 2294, 2296 can include axiallyextending lumens 2201. Distal ends of the lumens 2201 can be configuredto receive the proximal end portions of the control member tubes 2270.Proximal ends of the lumens 2201 can be configured to receive portionsof the locking members 2292.

The locking members 2292 can be configured to selectively controlrelative movement between a clasp control member 2224 and the respectivefirst or second side portion 2294, 2296 of the actuator member 2290. Thelocking members 2292 can comprise a lock configuration, which preventsrelative movement between a clasp control member 2224 and the respectivefirst or second side portion 2294, 2296, and a release configuration,which allows relative movement between a clasp control member 2224 andthe respective first or second side portion 2294, 2296. In someembodiments, the locking members 2292 can also comprise one or moreintermediate configurations (i.e., in addition to the lock and releaseconfiguration) which allows relative movement between a clasp controlmember 2224 and the respective first or second side portion 2294, 2296,but the force required to cause the relative movement is greater thanwhen the locking members 2292 are in the release configuration.

As shown in the illustrated embodiment, the locking members 2292 can beconfigured similar to stopcock valves. Thus, rotating knobs 2203 in afirst direction (e.g., clockwise) can increase the frictional engagementbetween the locking members 2292 on the clasp control members 537 andmake relative movement between a clasp control member 2224 and therespective first or second side portion 2294, 2296 more difficult orprevent it altogether. Rotating knobs 2203 in a second direction (e.g.,counterclockwise) can decrease the frictional engagement between thelocking members 2292 on the clasp control members 537 and make relativemovement between a clasp control member 2224 and the respective first orsecond side portion 2294, 2296 easier. In other embodiments, actuationlocking members 2292 can comprise other configurations configured forpreventing relative movement between the locking members 2292 on theclasp control members 537.

The flushing mechanism 2252 can comprise a flushing tube 2205 and avalve 2207 (e.g., a stopcock valve). A distal end of the flushing tube2205 can be coupled to and in fluidic communication with the flushinglumen 2266 and thus with the actuation shaft lumen 2262 of the main body2254. A proximal end of the flushing tube 2205 can be coupled to thevalve 2207. In this manner, the flushing mechanism 2252 can beconfigured for flushing (e.g., with a saline solution) the outer shaft2220 prior to inserting the outer shaft 2220 into a patient'svasculature.

The clasp control members 537 can be configured to manipulate theconfiguration of the clasps 530, as further described below. As shown inFIG. 148, each of the clasp control members 537 can be configured as asuture (e.g., wire or thread) loop. Proximal end portions of the controlmembers 537 can extend proximally from the proximal end portion of theclasp control mechanism 2250 and can be releasably coupled to thelocking mechanisms 2292 of the clasp control mechanism 2250.

From the locking mechanisms 2292, the clasp control members 537 can formloops extending distally through the lumens 2201 of the clasp controlmechanism 2250, through the control member tubes 2270, the controlmember lumens 2264, 2282 of the handle 2222, and through the controlmember lumens 2240 of the outer shaft 2220. The clasp control members537 can extend radially outwardly from the lumens 2240, for example,through the ports 2233 (FIG. 146) of the coupler 2214. The clasp controlmembers 537 can then extend through openings 535 of the clasps 530. Theclasp control members 537 can then extend proximally back to the coupler2214, radially inwardly through the ports 2233 of the coupler 2214, andthen proximally through the outer shaft 2220 and the handle 2222, and tothe locking mechanisms 2292 of the clasp control mechanism 2250.

In FIG. 148, the clasp control members 537 are shown slacken and theclasps 530 are partially open in order to illustrate the clasp controlmembers 537 extending through the openings 535 of the clasps 530.However, ordinarily when the clasp control members 537 are slacken, theclasps 530 would be in the closed configuration.

As shown in the illustrated embodiment, each of the clasp controlmembers 537 can extend through multiple lumens 2240 of the outer shaft2220. For example, each of the clasp control members 537 can be loopedthrough two of the lumens 2240. In other embodiments, each of the claspcontrol members 537 can be disposed in a single lumen 2240. In yet otherembodiments, multiple clasp control members 537 can be disposed in asingle lumen 2240.

With the clasp control members 537 coupled to the clasps 530, the claspcontrol mechanism 2250 can be used to actuate the clasps 530 betweenopen and closed configurations. The clasps 530 can be opened by movingthe actuator member 2290 proximally relative to the knob 2226 and thehousing 2246. This increases tension of the clasp control members 537and causes the clasp 530 to move from the closed configuration to theopen configuration. The clasps 530 can be closed by moving the actuatormember 2290 distally relative to the knob 2226 and the housing 2246.This decreases tension on the clasp control members 537 and allows theclasp 530 to move from the open configuration to the closedconfiguration. The clasps 530 can be individually actuated by removingthe pin 2298 and moving the first or second side portions 2294, 2296relative to each other, the knob 2226, and the housing 2246.

When the handle 2222 is assembled as best shown in FIGS. 150-151, theactuation shaft 512 can extend distally from the knob 2226, through theactuation tube 2268, through the actuation lumens 2262, 2280 of thehousing 2246, through the actuation lumen 2238 of the outer shaft 2220,and through the coupler 2214.

Referring now to FIGS. 153-160, the delivery assembly 2200 is used, forexample, to implant the prosthetic spacer device 500 in native mitralvalve MV of a heart H using a transseptal delivery approach. FIGS.153-160 are similar to FIGS. 15-20, described above, that show theimplantable prosthetic device 100 being implanted in the heart H andFIGS. 35-46, described above, that show the implantable prostheticdevice 500 being implanted in the heart H. Although not shown, a guidewire can be inserted into the patient's vasculature (e.g., a femoralvein) through an introducer sheath. The guide wire can be advancedthrough the femoral vein, through the inferior vena cava, into the rightatrium, through the interatrial septum IAS (e.g., via the fossa ovalis),and into the left atrium LA. The first sheath 2216 of the first catheter2204 can be advanced over the guide wire such that a distal end portionof the first sheath 2216 is disposed in the left atrium LA, as shown inFIG. 153.

With the prosthetic spacer device 500 coupled to the third catheter 2208(e.g., as shown in FIG. 145) and configured in a radially compressed,delivery configuration, the prosthetic spacer device 500 can be loadedinto the first sheath 2216 at a distal end of the second sheath 2218 ofthe second catheter 2206. The first sheath 2216 retains the prostheticspacer device 500 in the delivery configuration. In some embodiments,the radially compressed, delivery configuration can be an axiallyelongated configuration (e.g., like the configuration shown in FIG.153). In other embodiments, the radially compressed, deliveryconfiguration can be an axially foreshorten configuration (e.g., similarto the configuration shown in FIG. 155). The second catheter 2206 alongwith the prosthetic spacer device 500 and the third catheter 2208 canthen be advanced together through the first catheter 2204 such that adistal end portion of the sheath 2218 exposed from the distal endportion of the first sheath 2216 and is disposed in the left atrium LA,as shown in FIG. 153.

As shown in FIG. 153, the prosthetic spacer device 500 can be exposedfrom the first sheath 2216 by distally advancing the outer shaft 2220and the actuation shaft 512 of the third catheter 2208 relative to thefirst sheath 2216 and/or retracting the first sheath 2216 relative tothe outer shaft 2220 and the actuation shaft 512, thus forcing thepaddles 520, 522 of the anchors 508 out of the first sheath 2216. Onceexposed from the first sheath 2216, the paddles 520, 522 can be foldedby retracting the actuation shaft 512 of the third catheter 2208relative to the outer shaft 2220 of the third catheter 2208 and/or byadvancing the outer shaft 2220 relative to the actuation shaft 512,causing the paddles 520, 522 to bend from the configuration shown inFIG. 153, to the configuration shown in FIG. 154, and then to theconfiguration shown in FIG. 155. This can be accomplished, for example,by placing the actuation lock mechanism 2248 in the releaseconfiguration (e.g., by rotating the knob 2288 counterclockwise relativeto the handle 2222) and then moving the knob 2226 proximally relative tothe housing 2246. Another option is to set the locking knob 2288 tomaintain enough friction that you can actively slide the actuation wireor shaft 512 but the actuation wire or shaft will not move on its own.At any point in the procedure, the physician can lock the relativeposition of the actuation shaft 512 and the outer shaft 2220, and thusthe position of the paddles 520, 522, by actuating the actuation lockingmechanism 2248.

The prosthetic spacer device 500 can then be positioned coaxial relativeto the native mitral valve MV by manipulating (e.g., steering and/orbending) the second sheath 2218 of the second catheter 2206, as shown inFIG. 155. The prosthetic spacer device 500 can also be rotated (e.g., byrotating the housing 2246) relative to the native mitral valve MV suchthat the paddles 520, 522 align with native leaflets 20, 22 of themitral valve MV.

The paddles 520, 522 of the prosthetic spacer device 500 can then bepartially opened (i.e., moved radially outwardly relative to thecoaption element 510) to the configuration shown in FIG. 156 by movingthe knob 2226 distally relative to the housing 2246. The prostheticspacer device 500 can then be advanced through the annulus of the nativemitral valve MV and at least partially into the left ventricle LV. Theprosthetic spacer device 500 is then partially retracted such that thepaddles 520, 522 are positioned behind the ventricular portions of theleaflets 20, 22 (e.g., at the A2/P2 positions) and the coaption element510 is disposed on the atrial side of the leaflets 20, 22.

In this configuration, the native leaflets 20, 22 can be securedrelative to the paddles 520, 522 by capturing the native leaflets withthe clasps 530. The native leaflets 20, 22 can be grasped simultaneouslyor separately by actuating the actuator member 2290. For example, FIG.157 shows separate leaflet grasping. This can be accomplished byremoving the pin 2298 from the actuator member 2290 and moving the firstor second side portions 2294, 2296 relative to each other, the knob2226, and the housing 2246. Moving the first or second side portions2294, 2296 distally relative to the knob 2226 and the housing 2246closes the clasps 530 on the native leaflets 20, 22 (e.g., as shown bythe left clasp 530 as illustrated in FIG. 157). Moving the first orsecond side portions 2294, 2296 proximally relative to the knob 2226 andthe housing 2246 opens the clasps 530 (e.g., as shown by the right clasp530 as illustrated in FIG. 157). Once a clasp 530 is closed, a physiciancan re-open the clasp 530 to adjust the positioning of the clasp 530.

With both of the native leaflets 20, 22 secured within the clasps 530,the physician can move the knob 2226 proximally relative to the housing2246. This pulls the paddles 520, 522 and thus the native leaflets 20,22 radially inwardly against the coaption element 510, as shown in FIG.158. The physician can then observe the positioning and/or reduction inregurgitation. If repositioning or removal is desired the physician canre-open the paddles 520, 522 and/or the clasps 530.

Once the desired positioning and/or reduction in regurgitation isachieved, the physician can release the prosthetic spacer device 500from the delivery apparatus 2202. The clasps 530 can be released fromthe delivery apparatus 2202 by releasing the clasp control members 537from the locking members 2292 and unthreading the clasp control members537 from the openings 535 of the clasps 530. The cap 514 of theprosthetic spacer device 500 can be released from the delivery apparatus2202 by rotating the knob 2226 in the second direction relative to thehousing 2246 such that the actuation shaft 512 withdraws from the bore516A. The actuation shaft 512 can then be retracted proximally throughthe prosthetic spacer device 500 by pulling the knob 2226 proximallyrelative to the housing 2224. The proximal collar 511 of the prostheticspacer device 500 can be released from the delivery apparatus 2202 byretracting the actuation shaft 512 proximally relative to the coupler2214 such that the distal end portion of the actuation shaft 512withdraws from the eyelets 2234 of the coupler 2214. This allows theflexible arms 2228 of the coupler 2214 to move radially outwardly awayfrom the projections 511A of the proximal collar 511. The stabilizermembers 2230 of the coupler 2214 can then be withdrawn from the guideopenings 511B of the proximal collar 511 by pulling the housing 2246proximally, thereby releasing the prosthetic spacer device 500 from thedelivery apparatus 2202 as shown in FIG. 159.

The shafts 512, 2220 of the third catheter 2208 can then be retractedproximally into the second sheath 2218 of the second catheter 2206, andthe second sheath 2218 of the second catheter 2206 can be retractedproximally into the first sheath 2216 of the first catheter 2204. Thecatheters 2204, 2206, 2208 can then be retracted proximally and removedfrom the patient's vasculature.

With the prosthetic spacer device 500 implanted at the A2/P2 position,the native mitral valve MV comprises a double orifice during ventriculardiastole, as shown in FIG. 160. During ventricular systole, the sidesurfaces of the native leaflets 20, 22 can coapt all the way around theprosthetic spacer device 500 to prevent or reduce mitral regurgitation.

Referring now to FIGS. 161-162, an exemplary embodiment of a handle 2300for the delivery apparatus 2200 is shown. Referring to FIG. 161, thehandle 2300 can comprise a housing 2302, an actuation control mechanism2304, the clasp control mechanism 2250, and a flushing mechanism (notshown, but see, e.g., the flushing mechanism 2252 in FIG. 150). Thehousing 2302 can include a main body 2306 and the nose portion 2256. Thenose portion 2256 of the housing 2302 can be coupled to a proximal endportion of the outer shaft 2220. The actuation control mechanism 2304,the clasp control mechanism 2250, and a flushing mechanism 2252 can becoupled to a proximal end of the main body 2306 of the housing 2302.

The handle 2300 can be configured similar to the handle 2222, exceptthat the handle 2300 is configured such that rotational movement of thefirst knob 2318 of the actuation control mechanism 2304 relative to thehousing 2302 causes axial movement of the actuation tube 2268 and theactuation shaft 512; whereas, the handle 2222 is configured such thataxial movement of the knob 2226 relative to the housing 2246 causesaxial movement of the actuation tube 2268 and the actuation shaft 512.

As mentioned above, the housing 2302 can include a main body 2306 andthe nose portion 2256. Referring to FIG. 162, the main body 2306 of thehousing 2302 can comprise an actuation lumen 2308, control member lumens2310, and a flange portion 2312. The flange portion 2312 can extendaxially from a proximal end portion of the main body 2306 and annularlyaround the actuation lumen 2308.

The flange portion 2312 of the main body 2306 can comprise one or morecircumferential grooves 2314, a bore (not shown), and a guide pin 2316.The grooves 2314 can be configured to interact with the actuationcontrol mechanism 2304, as further described below. The bore can extendradially inwardly from an outside diameter to an inside diameter of theflange portion 2312 and can be configured to receive the guide pin 2316.The guide pin 2316 can be partially disposed in the bore and can extendradially inwardly from the bore such that the guide pin 2316 protrudesinto the actuation lumen 2308.

Referring still to FIG. 162, the actuation control mechanism 2304 cancomprise a first knob 2318, attachment pins 2320, a drive screw 2322, acollet 2324, and a second knob 2326. The first knob 2318 can have adistal end portion 2328 and a proximal end portion 2330. The first knob2318 can be configured such that the inside diameter of the distal endportion 2328 is relatively larger than the inside diameter of theproximal end portion 2330. The distal end portion 2328 can compriseopenings 2332 that extend radially inwardly from an outside diameter tothe inside diameter of the distal end portion 2328.

Referring again to FIG. 161, the inside diameter of the distal endportion 2328 can be configured such that the distal end portion 2328 ofthe first knob 2318 can extend over the flange portion 2312 of the mainbody 2306. The openings 2332 (FIG. 162) can be configured to axiallyalign with the grooves 2314 when the first knob 2318 is disposed overthe flange 2312. The attachment pins 2320 can be configured so as toextend through the openings 2332 of the first knob 2318 and into grooves2314 of the flange 2312. In this manner, the attachment pins 2320 allowrelative rotational movement and prevent relative axial movement betweenthe first knob 2318 and the flange 2312.

The inside diameter of the proximal end portion 2330 of the first knob2318 can have internal threads (not shown) configured to engagecorresponding external threads 2334 of the drive screw 2322. As shown inFIG. 162, the drive screw 2322 can have a slot 2336 that extends axiallyacross the external threads 2334. The slot 2336 can be configured toreceive the guide pin 2316 of the flange portion 2312. As such, when thehandle 2300 is assembled (FIG. 161) and the first knob 2318 is rotatedrelative to the flange 2316, the guide pin 2316 prevents the drive screw2322 from rotating together with the first knob 2318 and causes thedrive screw 2322 to move axially relative to the first knob 2318 and theflange 2316. In this manner, rotating the first knob 2318 in a firstdirection (e.g., clockwise) moves the drive screw distally relative tothe housing 2306, and rotating the first knob 2318 in a second direction(e.g., counterclockwise) moves the drive screw proximally relative tothe housing 2306.

The drive screw 2322 can also have a lumen 2338, as shown in FIG. 162.The lumen 2338 can be configured such that the actuation tube 2268 canextend through the drive screw 2322. The lumen 2338 can be configuredsuch that a distal end portion 2340 of the collet 2324 can also beinserted into a proximal end portion of the lumen 2338.

The second knob 2326 can comprise a first, distal portion 2342 and asecond, proximal portion 2344. The first portion 2342 can includeinternal threads (not shown) corresponding to the external threads 2334of the drive screw 2322. The second portion 2344 can comprise a conicalinside surface configured to engage a proximal end portion 2346 of thecollet 2324.

When assembled (FIG. 161), the actuation tube 2268 can extend throughthe lumen 2338 of the drive screw 2322, through the collet 2324, andthrough the second knob 2326. The second knob 2326 can be disposed overthe collet 2324 and the internal threads of the first portion 2342 ofthe second knob can threadably engage the external threads 2334 of thedrive screw 2322. Accordingly, rotating the second knob 2326 in a firstdirection (e.g., clockwise) relative to the drive screw 2322 causes thesecond portion 2344 of the second knob 2326 to move toward the proximalend portion 2346 of the collet 2324 and thus urges the collet 2324radially inwardly against the actuation tube 2268. As a result, theactuation tube 2268 and the drive screw 2322 move axially together whenthe first knob 2318 is rotated relative to the housing 2306. Rotatingthe second knob 2326 in a second direction (e.g., counterclockwise)relative to the drive screw 2322 causes the second portion 2344 of thesecond knob 2326 to move away from the proximal end portion 2346 of thecollet 2324 and thus allows the collet 2324 to move radially outwardlyrelative to the actuation tube 2268. As a result, the actuation tube2268 and the drive screw 2322 can move relative to each other.

With the prosthetic spacer device 500 coupled to the actuation shaft 512and the outer shaft 2220 of the delivery apparatus 2202, the physiciancan use the actuation control mechanism 2304 of the handle 2300 tomanipulate the paddles 520, 522 of the prosthetic spacer device 500relative to the spacer member 202 of the prosthetic spacer device 500.The actuation control mechanism 2304 can be activated by rotating thesecond knob 2326 in the first direction relative to the drive screw 2322to secure the actuation tube 2268 and thus the actuation shaft 512 tothe drive screw 2322. The physician can then rotate the first knob 2318relative to the housing 2302, which causes the drive screw 2322 and thusthe actuation tube 2268 and the actuation shaft 512 to move axiallyrelative to the housing 2302 and thus the outer shaft 2220. This, inturn, causes the paddles 520, 522 (which are coupled to the actuationshaft 512 via the cap 514) to move relative to the coaption element 510(which is coupled to the outer shaft 2220 via coupler 2214 and theproximal collar 511).

The prosthetic spacer device 500 can be released from the deliveryapparatus 2202 by rotating the second knob 2326 in the second directionrelative to the drive screw 2322. This allows the actuation tube 2268and thus the actuation shaft 512 to move relative to the drive screw2322. The shafts 512, 2220 of the delivery apparatus 2202 can then beremoved from the respective collars 3508, 3510 of the prosthetic spacerdevice 500, as described above.

Configuring a delivery apparatus with the actuation control mechanism2304 can provide several advantages. For example, the rotational forcesrequired to actuate the first knob 2318 of the handle 2300 can be lessthan the axial forces required to actuate the knob 2226 of the handle2300.

The actuation control mechanism 2304 can also provide relatively moreprecise control of the paddles 520, 522 because the axial movement ofthe actuation shaft 512 is controlled by rotation of the first knob 2318and the thread pitch of the drive screw 2322 rather than be axialmovement of the knob 2226. In other words, the actuation controlmechanism 2304 can be configured, for example, such that one rotation ofthe first knob 2318 moves the actuation shaft 512 a small axial distance(e.g., 1 mm): whereas, it may be relatively more difficult to axiallymove the knob 2226 and thus the shaft 512 in small increments (e.g., 1mm).

Additionally, the actuation control mechanism 2304 can prevent or reduceinadvertent movement and release of the actuation shaft 512. Forexample, because the actuation control mechanism 2304 requiresrotational movement of the first knob 2318 to move the actuation shaft512, it can prevent or reduce the likelihood that the actuation shaft512 will move if the knob 2226 is inadvertently contacted. Also, thephysician has to rotate the second knob 2326 to release the actuationtube 2268 from the drive screw 2322 before the physician can rotate theknob 2226 to release the actuation shaft 512 from the cap 514 of theprosthetic spacer device 500 and proximally retract the actuation shaft512. This two-step release process could reduce the likelihood of aphysician inadvertently releasing the prosthetic spacer device 500 fromthe delivery apparatus 2202.

FIGS. 163-164 show exemplary embodiments of a coupler 2400 and aproximal collar 2402. Although not shown, the coupler 2400 can becoupled to the distal end portion of the outer shaft 2220 (FIG. 149) ina manner similar to the coupler 2214. As shown, the proximal collar 2402can be coupled to a proximal end portion of the coaption element 510 ina manner similar to the proximal collar 511 (FIG. 146). As such, thecoupler 2400 and the proximal collar 2402 can be used, for example, inlieu of the coupler 2214 and the proximal collar 514 of the deliveryassembly 2200, respectively, to releasably couple the prosthetic spacerdevice 500 to the outer shaft 2220 (FIG. 149).

Referring to FIG. 164, the coupler 2400 can comprise anaxially-extending lumen 2404 and a plurality of radially-extendingopenings 2406. The lumen 2404 can be configured to receive the actuationshaft 512 (FIG. 163). The openings 2406 can be configured to receive theproximal collar 2402, as further described below.

The proximal collar 2402 can comprise a plurality ofproximally-extending tabs or fingers 2408. Free end portions 2410 of thefingers 2408 can have radially-extending projections 2412 formedthereon. The fingers 2408 can be configured to pivot between a first orresting state (FIG. 164) and a second or deflected state (FIG. 163). Inthe first state, the free end portions 2410 of the fingers 2408 pressradially inwardly against each other. In the second state, the free endportions 2410 of the fingers 2408 are radially spaced from each other.

Referring to FIG. 163, the coupler 2400 and the proximal collar 2402 bereleasably coupled together by positioning the fingers 2408 of theproximal collar 2402 within the coupler 2400. The actuation shaft 512can then be advanced through the lumen 2404 of the coupler 2400 andthrough the fingers 2408 of the proximal collar 2400, thus causing thefree ends 2410 of the fingers 2408 to pivot radially-outwardly from thefirst state to the second state. The projections 2412 of the fingers2408 and the openings 2406 of the coupler 2400 can be rotationallyaligned such that the projections 2412 extend into the openings 2406,thereby releasably coupling the coupler 2400 to the proximal collar2402. The coupler 2400 can be released from the proximal collar 2402 byretracting the actuation shaft 512 from the finger 2408 of the proximalcollar 2402. This allows the free end portions 2410 of the fingers 2408to pivot from the second state back to the first state and causes theprojections 2412 of the fingers 2408 to withdraw from the openings 2406of the coupler 2402, thus releasing the coupler 2400 from the proximalcollar 2402.

In some embodiments, the fingers 2408 of the proximal collar 2402 can beconfigured to create a hemostatic seal when the fingers 2408 are in thefirst state. This can, for example, prevent or reduce blood from flowingthrough the proximal collar 2402 when the prosthetic spacer device 500is implanted in a patient.

FIGS. 165-166 show exemplary embodiments of a cap 2500, an actuationshaft 2502, and a release member (e.g., wire) 2504, which can be used,for example, with the delivery assembly 2200. Although not shown, thecap 2500 can be coupled to the distal portion of the prosthetic spacerdevice 500. A proximal portion (not shown) of the actuation shaft 2502can be coupled to the actuation tube 2268 and the knob 2226. From theproximal end portion, the actuation shaft 2502 can extend distallythrough the handle 2222 (FIG. 150), through the outer shaft 2220 (FIG.150), and into the prosthetic spacer device 500 (FIG. 145). A distal endportion of the actuation shaft 2502 can be releasably coupled to the cap2500 of the prosthetic spacer device 500. As such, the cap 2500 and theactuation shaft 2502 can be used, for example, in lieu of the cap 514and the actuation shaft 512 of the delivery assembly 2200, respectively.

Referring to FIG. 166, the cap 2500 can comprise a central bore 2506 anda tongue or tab 2508 formed (e.g., laser cut) in a side surface 2510 ofthe cap 2500. The tongue 2508 can have an opening 2512 formed (e.g.,laser cut) therein. The central bore 2506 can be configured to receive adistal end portion of the actuation shaft 2502. The tongue 2508 can bepivotable relative to the side surface 2508 of the cap 2500 from a firstor resting configuration (FIG. 166) to a second or deflectedconfiguration (FIG. 165). In the first configuration, the tongue 2508can be flush with the side surface 2510. In the second configuration,the tongue 2508 can extend radially inwardly relative to the sidesurface 2510 to protrude into the central bore 2506.

The tongue 2508 can be used, for example, to releasably couple the cap2500 to the actuation shaft 2502, as shown in FIGS. 165 and 166. Forexample, the actuation shaft 2502 can be inserted into the central bore2506 of the cap 2500. The tongue 2508 can then be pushed radiallyinwardly from the first configuration to the second configuration suchthat the tongue 2508 presses against the actuation shaft 2502. Therelease member 2504 can then be advanced distally such that a distal endportion 2514 of the release member 2504 extends through the opening 2512of the tongue 2508. Thus, the release member 2504 retains the tongue2508 in the second configuration against the actuation shaft 2502,thereby releasably coupling the cap 2500 to the actuation shaft 2502.

The cap 2500 can be released from the actuation shaft 2500 by retractingthe release member 2504 proximally such that the distal end portion 2514of the release member 2504 withdraws from the opening 2512 of the tongue2508. This allows the tongue to move radially outwardly from the secondstate back to the first state, thereby releasing the cap 2500 from theactuation shaft 2502.

This configuration can provide several advantages. For example, in someembodiments, the cap 2500 and the actuation shaft 2502 can be formedwithout threads. Removing the threads can make manufacturing the cap2500 and the actuation shaft 2502 easier and/or less expensive. Removingthe threads from the actuation shaft 2502 can also reduce the likelihoodthe actuation shaft 2502 could catch or snag on another component of thedelivery assembly 2200.

FIGS. 167-168 show exemplary embodiments of a coupler 2600, a proximalcollar 2602, a cap 2604, and an actuation shaft 2606, which can be used,for example, with the delivery assembly 2200. Referring to FIG. 167, thecoupler 2600 can be coupled to the distal end portion of the outer shaft2220. The proximal collar 2602 can be coupled to the proximal portion ofthe prosthetic spacer device 500 (shown schematically in partialcross-section), and the cap 2604 can be coupled to the the distalportion of the prosthetic spacer device 500. A proximal portion (notshown) of the actuation shaft 2606 can be coupled to the actuation tube2268 and the knob 2226. From the proximal end portion, the actuationshaft 2606 can extend distally through the handle 2222 (FIG. 150),through the outer shaft 2220 (FIG. 150), and into the prosthetic spacerdevice 200 (FIG. 145). A distal end portion of the actuation shaft 2606can be releasably coupled to the cap 2604 of the prosthetic spacerdevice 500. As such, the coupler 2600, the proximal collar 2602, the cap2604, and the actuation shaft 2606 can be used, for example, in lieu ofthe coupler 2214, the proximal collar 511, the cap 514, and theactuation shaft 512 of the delivery assembly 2200, respectively.

Referring to FIG. 168, the coupler 2600 can comprise a connectionportion 2608, a plurality of pins 2610 (e.g., three in the illustratedembodiment), and one or more securing members 2612 (e.g., three in theillustrated embodiment). The pins 2610 and the securing members can becoupled to and extend distally from the connection portion 2600.

The connection portion 2608 can have an axially-extending lumen 2614configured to slidably receive the actuation shaft 2606. In someembodiments, the connection portion 2608 can also have a recessedoutwardly facing surface 2615 configured to be inserted into the distalend portion of the outer shaft 2220, as shown in FIG. 167.

As best shown in FIG. 168, the pins 2610 can be spaced circumferentiallyrelative to each other and relative to the securing members 2612. Thesecuring members 2612 can be spaced circumferentially relative to eachother. In some embodiments, the pins 2610 and the securing members 2612can be configured in an alternating type pattern (e.g., pin-securingmember-pin and so on) on the connection portion 2608.

Referring to FIG. 167, the pins 2610 can be configured to extend intoopenings 2616 of the proximal collar 2602. In certain embodiments, thesecuring members 2612 can be suture loops. The securing members 2612 canbe configured to extend through the openings 2616 of the proximal collar2602 and around the actuation shaft 2606. For clarity, only one securingmember 2612 is shown extending around the actuation shaft 2606 in FIG.167.

Referring again to FIG. 168, in addition to the openings 2616, theproximal collar 2602 can comprise a central lumen 2618 disposed radiallyinward from the openings 2616. The central lumen 2618 can extend axiallyand can be configured to slidably receive the actuation shaft 2606, asshown in FIG. 167.

The cap 2604 can be configured in a sleeve-like manner such that theactuation shaft 2606 can slidably extend through the cap 2604, as shownin FIG. 167.

The actuation shaft 2606 can comprise a radially-expandable portion 2620disposed at or near the distal end portion 2622 of the actuation shaft2606. The radially-expandable portion 2620 can be configured to beselectively expandable from a compressed configuration to an expandedconfiguration. The radially-expandable portion 2620 can be configuredsuch that an outside diameter of the radially-expandable portion 2620 isless than the inside diameter of the cap 2604, the central lumen 2618 ofthe proximal collar 2602, and the lumen 2614 of the coupler 2600 whenthe radially-expandable portion 2620 is in the compressed configuration.When the radially expandable portion 2620 is in the expandedconfiguration, the outside diameter of the radially-expandable portion2620 is greater than the inside diameter of the cap 2604. Thus, in theexpanded configuration, the radially-expandable portion 2620 can preventthe distal end portion 2622 from moving proximally relative to the cap2604.

As shown in FIG. 167, the prosthetic spacer device 500 can be releasablycoupled to the outer shaft 2220 and the actuation shaft 2606 byinserting the pins 2610 and the securing members 2612 through respectiveopenings 2616 in the proximal collar 2602. With the radially-expandableportion 2620 in the compressed configuration, the actuation shaft 2606can be advanced distally through the lumen 2614 of the coupler 2600,through the lumen 2618 and the securing members 2612 of the proximalcollar 2602, and through the cap 2604 such that the radially-expandableportion 2620 is disposed distal relative to the cap 2604. Theradially-expandable portion 2620 of the actuation shaft 2606 can then beexpanded from the compressed configuration to the expandedconfiguration, thus releasably coupling the prosthetic spacer device 500to the outer shaft 2220 and the actuation shaft 2606.

The prosthetic device 500 can be released from the outer shaft 2220 andthe actuation shaft 2606 by compressing the radially-expandable portion2620 of the actuation shaft 2606 and proximally retracting the actuationshaft 2606 through the cap 2604, through the securing members 2612 andthe lumen 2618 of the proximal collar 2602. The outer shaft 2220 canthen be retracted proximally relative to the prosthetic spacer device500 such that the pins 2610 and the securing members 2612 withdraw fromthe openings 2616 in the proximal collar 2602, thus releasing theprosthetic spacer device 500 from the outer shaft 2220 and the actuationshaft 2606.

FIGS. 169-170 show an exemplary embodiment of clasp control members2700, which can be used, for example, in lieu of the clasp controlmembers 537 of the delivery assembly 2200. Referring to FIG. 170, theclasp control members 2700 can comprise sleeves 2702, connecting members2704, and release members 2706. The connecting members 2704 and therelease members 2706 can extend axially through and can be movablerelative to the sleeves 2702.

Proximal end portions (not shown) of the sleeves 2702 can be coupled tothe control member tubes 2270, and distal end portions of the sleeves2708 can be releasable coupled to the clasps 530 of the prostheticspacer device 500 by the connecting members 2704 and the release members2706, as further described below.

The connecting members 2704 can, for example, be suture loops thatextend distally from the clasp control mechanism 2250 of the deliveryapparatus 2202, through the control member tubes 2270, through thesleeves 2702, and through the openings 535 of the clasps 530. Theconnecting members 2704 can be releasably coupled to the clasps 530 theprosthetic spacer device 500 by the release members 2706.

The release members 2706 can, for example, be wires that extend distallyfrom the clasp control mechanism 2250 of the delivery apparatus 2202,through the control member tubes 2270, through the sleeves 2702, andthrough the loops of the connecting members 2704. In this manner, therelease members 2706 releasably couple the connecting members 2704 andthus the sleeves 2702 to the clasps 530 by preventing the connectionmembers 2704 from withdrawing through the openings 535 of the clasps530. The connection members 2704 can be released from the clasps 530 bywithdrawing the release members 2706 from the loops of the connectingmembers 2704 and withdrawing the connecting members 2704 from theopenings 535 of the clasps 530.

With the sleeves 2702 releasably coupled to the clasps 530 of theprosthetic spacer device 500 by the connecting members 2704 and therelease members 2706, the clasps 530 can be actuated (either together orseparately) by moving the sleeves 2702 axially relative to the outershaft 2220 and the actuation shaft 512. This can be accomplished, forexample, by moving the actuator member 2290, which are coupled to thesleeves 2702 via the control tubes 2268, relative to the housing 2246and actuation tube 2268. Moving the actuation member 2290 proximallyrelative to the housing 2246 and actuation tube 2268 can open the clasps530 and moving the actuation member 2290 distally relative to thehousing 2246 and actuation tube 2268 can close the clasps 530.

Because the sleeves 2702 are relatively rigid (e.g., compared to theclasp control members 537), the sleeves 2702 can be used to push theclasps 530 closed (either in lieu of or in addition to the bias of theclasps 530 to the closed position). This pushability can help to ensurethe native leaflets are grasped within the clasps 530 and thus securedto the paddles 520, 522.

FIG. 171 shows an exemplary embodiment of a guide rail 2800. The guiderail 2800 can, for example, be coupled to the clasps 530 of theprosthetic spacer device 500. In some embodiments, the clasp controlmember 2700 can be releasably coupled to the guide rail 2800 in asnare-like manner similar to that described above with respect to FIG.170.

Coupling a clasp control member 2700 to the guide rail 2800 rather thandirectly to the clasps 530 allows the clasp control member 2700 to slidelongitudinally along the guide rail 2800 as the clasp 530 moves betweenthe open and the closed configurations. This can, for example, allow theclasp control member 2700 to maintain a relatively constant anglerelative to the paddles 520, 522 as the clasps 530 are actuated. Forexample, the clasp control member 2700 can slide outwardly toward afirst side portion 2802 of the guide rail 2800 when the clasp 206 ispulled open, and the clasp control member 2700 can slide inwardly towarda second side portion 2804 of the guide rail 2800 when the clasp 530 ispushed closed. This can therefore reduce the force required to actuatethe clasp control member 2700. For example, the sleeves 2702 can remainmore substantially straight as the movable portion of the clasp 530swings through its full arc of motion. This is due to the slidingmovement on the guide rail 2800. By sliding and remaining substantiallystraight, the amount of bending of the sleeves is limited.

FIG. 172 shows an exemplary embodiment of a shaft 2900. The shaft 2900can be used, for example, with the delivery apparatus 500 in lieu of theouter shaft 2220 of the third catheter 508. The shaft 2900 can comprisea plurality of axially extending lumens, including an actuation shaftlumen 2902 and a plurality of control member lumens 2904 (e.g., four inthe illustrated embodiment) disposed radially outwardly from theactuation shaft lumen 2902. The control member lumens 2904 can be spacedrelative to each other and can be evenly distributed circumferentiallyaround the actuation shaft lumen 2902. For example, each of the controlmember lumens 2904 can be located approximately 90 degrees from anadjacent control member lumen 2904.

The actuation shaft lumen 2902 can be configured to receive theactuation shaft 512, and the control member lumens 2904 can beconfigured to receive the clasp control members 537. The lumens 2902,2904 can also be configured such that the actuation shaft 512 and claspcontrol members 537 can be movable (e.g., axially and/or rotationally)relative to the lumens 2902, 2904, respectively. In particularembodiments, the lumens 2902, 2904 can comprise a liner or coating(e.g., PTFE) configured to reduce friction between the lumens 2902, 2904and the actuation shaft 512 and clasp control members 537, respectively.

The shaft 2900 can be formed from various materials, including metalsand polymers. For example, in one particular embodiment, the shaft 2900can comprise a first portion 2906, a second portion 2908, and a thirdportion 2910. The first portion 2906 be the radially outermost portion,the third portion 2910 can be the radially innermost portion, and thesecond portion 2908 can be disposed radially between the first and thirdportions 2906, 2910. In certain embodiments, the first and thirdportions 2906, 2910 can be formed from polymeric material (e.g., PEBAXor other material having a Type D Shore durometer value of 55D), and thesecond portion 2908 can be formed from a metallic material (e.g.,braided stainless steel).

Configuring the shaft 2900 in this manner can, for example, furtherimprove control of the distal end portion of the shaft 2900. Forexample, this configuration can prevent or reduce “whipping” (e.g.,sudden or abrupt movement) at the distal end portion of the shaft 2900when the shaft 2900 is rotated at the proximal end portion (e.g., byrotating the housing 2246 of the handle 2222). As such, a physician canmore precisely control the distal end portion of the shaft 2900 and thusmore precisely control the prosthetic spacer device (e.g., the spacerdevice 500) during the implantation procedure such as when the physicianrotates the prosthetic spacer device to align the anchors of theprosthetic spacer device with the native leaflets.

It should be noted that in certain embodiments the housing 2246 of thehandle 2222 can comprise four control member lumens 2264, 2282 (i.e.,four of each) that are coupled to the control member lumens 2904. Assuch, each portion of the clasp control members 537 can extend distallyin a separate lumen from the clasp control mechanism 2250 of the handle2222 to the prosthetic spacer device 500.

Referring to FIG. 173, the actuation wire 512 can be hollow so that atethering line or suture 3000 can be extended through the actuation wire512 to the device 500. The actuation wire 512 extends through the device500 and is attached to the cap 514. Retracting the tethering line 3000in the retraction direction X relative to the coupler 2200 reduces thelength of the tethering line 3000, thereby moving the coupler 2200toward the device 500 in a recapture direction Y.

Referring again to FIG. 173, the device 500 is shown in a closedposition having been delivered and implanted in the native mitral valve.Once the device 500 is implanted, the coupler 2200 is opened and movedaway from the device in a retraction direction X so that the performanceof the device 500 can be monitored to see if any adjustments may bedesirable. If further adjustments to the device 500 are desired, thetethering line 3000 is retracted in the retraction direction X so thatthe coupler 2200 moves in the recapture direction Y toward the device500.

Referring now to FIG. 174, the coupler 2200 has been moved into asuitable position to recapture the device 500. Once in position, theactuation lines 3002 for each moveable arm 2228 are retracted in anactuation direction A to cause the moveable arms 2228 to move in aclosing direction B close around the proximal collar 511 of the device500. In some embodiments, the tethering line 3000 is adjustedsimultaneously with the actuation lines 3002 to aid in recapturing thedevice 500 which may be moving around as the native mitral valve MVopens and closes.

Referring now to FIG. 175, the moveable arms 2228 are closed around theproximal collar 511. The actuation wire 512 is then moved in a distaldirection C, through the securing portions 2234 of the moveable arms2228 and into the device 500 along the tethering line 3000. To recaptureand secure the device 500, a threaded end 512B of the actuation wire 512is threaded into a threaded receptacle 516A of the cap 514 as shown inFIG. 176.

FIGS. 174A and 175B illustrate another example of a mechanism that canbe used to recouple the coupler 2200 to the collar 511 of the device500. In the example of FIGS. 174A and 175B, the actuation wire 512 canbe hollow so that a tethering line or suture 3000 can be extendedthrough the actuation wire 512 to the device 500. As in the embodimentillustrated by FIGS. 174 and 175, retracting the tethering line 3000 inthe retraction direction X moves the coupler 2200 toward the device 500in a recapture direction Y.

Referring now to FIGS. 174A and 174B, the coupler 2200 has been movedinto a suitable position to recapture the device 500. Once in position,a closing sleeve 3003 that fits around the moveable arms 2228 isadvanced over the coupler 2200 in a closing direction C to press themoveable arms 2228 inward in a closing direction D around the proximalcollar 511 of the device 500. In some embodiments, the tethering line3000 is adjusted simultaneously with the closing sleeve 3003 to aid inrecapturing the device 500 which may be moving around as the nativemitral valve MV opens and closes.

Referring now to FIG. 175A, the moveable arms 2228 are closed around theproximal collar 511. The actuation wire 512 is then moved in a distaldirection and into the device 500 along the tethering line 3000. Torecapture and secure the device 500, a threaded end 512B of theactuation wire 512 is threaded into a threaded receptacle 516A of thecap 514 as shown in FIG. 176.

Referring now to FIGS. 177-178, an exemplary implantable prostheticdevice 3100 is shown. The device 3100 includes an implantable prostheticdevice 3110 and a coupler 3120. An actuation shaft or wire 3130 canextend through the coupler 3120 to the device 3110 to open and close thedevice 3110. The device 3110 is similar to exemplary implantableprosthetic devices described in the present application and includes aproximal collar 3112 having an opening 3114 and radially disposedapertures 3116. The coupler 3120 has moveable arms or fingers 3122 thatcan be moved between open and closed positions. The moveable arms 3122include protrusions 3124 configured to engage the apertures 3116 of theproximal collar 3112 of the device 3110. The moveable arms 3122 arebiased inward so that moving the actuation shaft 3130 in a distaldirection Y through the coupler 3120 and between the moveable arms 3122spreads the moveable arms 3122 outwards so that the protrusions 3124engage the apertures 3116. In the illustrated embodiment, theprotrusions 3124 and apertures 3116 are tapered to ease engagement ofthe protrusions 3124 with the apertures 3116. Moving the actuation shaft3130 in a retraction direction X allows the moveable arms 3122 to moveinward so that the protrusions 3124 disengage the apertures 3116. Inthis way the device 3110 can be released and recaptured by the coupler3120.

Referring now to FIGS. 179-181, an exemplary implantable prostheticdevice 3200 is shown. The device 3200 includes an implantable prostheticdevice 3210 and a coupler 3220. An actuation shaft or wire 3230 canextend through the coupler 3220 to the device 3210 to open and close thedevice 3210. The device 3210 is similar to exemplary implantableprosthetic devices described in the present application and includes aproximal collar 3212 having an opening 3214 and radially disposedapertures 3216.

The coupler 3220 has moveable arms or fingers 3222 that can be movedbetween open and closed positions. The moveable arms 3222 includeprotrusions 3224 configured to engage the apertures 3216 of the proximalcollar 3212 of the device 3210. The moveable arms 3222 are biased inwardso that moving the actuation shaft 3230 in a distal direction Y throughthe coupler 3220 and between the moveable arms 3222 spreads the moveablearms 3222 outwards so that the protrusions 3224 engage the apertures3216. Moving the actuation shaft 3230 in a retraction direction X allowsthe moveable arms 3222 to move inward so that the protrusions 3224disengage the apertures 3216. In this way the device 3210 can bereleased and recaptured by the coupler 3220.

The actuation wire 3230 can be hollow so that a tethering line or suture3232 can be extended through the actuation wire 3230 to the device 3210.The actuation wire 3230 extends through the opening 3214 of the device3210 and is attached to securing portions 3218. Retracting the tetheringline 3232 in the retraction direction X (FIG. 180) reduces the length ofthe tethering line 3232, thereby moving the coupler 3220 toward thedevice 3210 such that the moveable arms 3222 are inserted into theopening 3214 of the device 3210 as shown in FIG. 180.

Referring now to FIG. 181, once the coupler 3220 has been moved intoposition to recapture the device 3210 the actuation wire 3230 is movedin the distal direction Y to recouple the coupler 3220 to the device3210. The actuation wire 3230 engages the moveable arms 3222, therebycausing the protrusions 3224 to move in an outward direction A to engagethe apertures 3216 of the device 3210. In the illustrated embodiment,the protrusions 3224 and apertures 3216 are tapered to ease engagementof the protrusions 3224 with the apertures 3216. In some embodiments,the tethering line 3232 is adjusted simultaneously as the actuationshaft 3230 is extended to take up slack in the actuation line andmaintain engagement between the coupler 3220 and device 3210.

Referring now to FIGS. 182-183, an exemplary implantable prostheticdevice 3300 is shown. The device 3300 includes an implantable prostheticdevice 3310 and a coupler 3320. An actuation shaft or wire 3330 canextend through the coupler 3320 to the device 3310 to open and close thedevice 3310. The device 3310 is similar to exemplary implantableprosthetic devices described in the present application and includes aproximal collar 3312 having an opening 3314 and radially disposedapertures 3316.

The coupler 3320 has moveable arms or fingers 3322 that can be movedbetween open and closed positions. The moveable arms 3322 include distalprotrusions 3324 configured to engage the apertures 3316 of the proximalcollar 3312 of the device 3310. The moveable arms 3324 also includeinternal protrusions 3326 having apertures 3328 configured to receivethe actuation shaft 3330. In the closed position, the internal apertures3328 are offset from the actuation shaft 3330. The actuation shaft 3330has a tapered end 3332 to engage the offset apertures 3328. Assuccessive apertures 3328 are engaged by the tapered end 3332 of theactuation shaft 3330, the moveable arms 3322 are moved outward to engagethe opening 3314.

The moveable arms 3322 are biased inward so that moving the actuationshaft 3330 in a distal direction Y through the coupler 3320 and betweenthe moveable arms 3322 spreads the moveable arms 3322 outwards so thatthe protrusions 3324 engage the apertures 3316. Moving the actuationshaft 3330 in a retraction direction X allows the moveable arms 3322 tomove inward so that the protrusions 3324 disengage the apertures 3316.In this way the device 3310 can be released and recaptured by thecoupler 3320. In some embodiments, the prosthetic device 3300 is similarto the device 3200 and includes a tethering line (not shown) that allowsthe device 3300 to be recaptured.

Referring now to FIGS. 183-184, an exemplary implantable prostheticdevice 3400 is shown. The device 3400 includes an implantable prostheticdevice 3410 and a coupler 3420. An actuation shaft or wire 3430 canextend through the coupler 3420 to the device 3410 to open and close thedevice 3410. The device 3410 is similar to exemplary implantableprosthetic devices described in the present application and includes aproximal collar 3412 having an opening 3414 and radially disposedapertures 3416.

The coupler 3420 has moveable arms or fingers 3422 that can be movedbetween open and closed positions. The moveable arms 3422 include distalprotrusions 3424 configured to engage the apertures 3416 of the proximalcollar 3412 of the device 3410. The moveable arms 3424 also includeinternal protrusions 3426 having apertures 3428 configured to receivethe actuation shaft 3430. In the closed position, the internal apertures3428 are offset from the actuation shaft 3430. The actuation shaft 3430has a tapered end 3432 to engage the offset apertures 3428. Assuccessive apertures 3428 are engaged by the tapered end 3432 of theactuation shaft 3430, the moveable arms 3422 are moved inward to engagethe opening 3414.

The moveable arms 3422 are biased outward so that moving the actuationshaft 3430 in a distal direction Y through the coupler 3420 and betweenthe moveable arms 3422 retracts the moveable arms 3422 inwards so thatthe protrusions 3424 engage the apertures 3416. Moving the actuationshaft 3430 in a retraction direction X allows the moveable arms 4622 tospread outward so that the protrusions 3424 disengage the apertures3416. In this way the device 3410 can be released and recaptured by thecoupler 3420. In some embodiments, the prosthetic device 3400 is similarto the device 3200 and includes a tethering line (not shown) that allowsthe device 3400 to be recaptured.

Referring to FIG. 186, an actuation shaft 3500 for placing and actuatingan implantable prosthetic device is shown. The actuation shaft 3500includes a hollow placement shaft 3510 and a hollow device shaft 3520that fit over a retaining shaft 3530 that holds the placement and deviceshafts 3510, 3520 together at a connection 3502. The placement shaft3510 extends from a delivery device 3504 and when coupled to the deviceshaft 3520 allows an implantable device 3506 to be placed in a suitablelocation for implantation. The location of the connection 3502 betweenthe placement shaft 3510 and the device shaft 3520 can be at a widevariety of different positions in an implantable device. For example,the connection 3502 may at a proximal portion of a device or may be at adistal portion of a device.

The positioning shaft 3510 can include a protruding portion 3512 and arecessed receiving portion 3514. The device shaft 3520 can also includea protruding portion 3522 and a recessed receiving portion 3524. Whenthe shafts 3510, 3520 are coupled, the protruding portion 3512 of theplacement shaft 3510 is received by the receiving portion 3524 of thedevice shaft 3520, and the protruding portion 3522 of the device shaft3520 is received by the receiving portion 3514 of the placement shaft3510.

The shafts 3510, 3520 can be connected in a wide variety of differentways. For example, the shaft 3510 can include a bore or channel 3516that is aligned with a bore or channel 3526 of the shaft 3520 when theprotruding portions 3512, 3522 are disposed in the receiving portions3514, 3524, respectively. When the openings 3516, 3526 are aligned andthe retaining shaft 3530 is placed into the openings 3516, 3526 in thedirection X, the shafts 3510, 3520 are retained together. When theretaining shaft 3530 is removed from the openings 3516, 3526 in thedirection Z, protruding portions 3512, 3522 can be removed from thereceiving portions 3514, 3524, such that the device 3506 is detachedfrom the placement shaft 3510.

Still referring to FIG. 186, in some embodiments, when the shafts 3510,3520 are secured to each other, an aperture 3540 is created at interface3542 between the shafts 3510, 3520. The aperture 3540 is configured tosecure a control line 3544 between the shafts 3510, 3520 to allow forseparate control of clasps or gripping members (not shown). That is, theaperture 3540 is configured such that the line 3544 does not moverelative to the aperture 3540 when the shafts 3510, 3520 are joinedtogether. Upon detachment of the shafts 3510, 3520, the line 3544 isreleased from the aperture 3540 and can be removed from the implantabledevice 3506. The line 3544 can then be retracted into the catheter torelease the clasps gripping members.

Referring now to FIG. 187, an actuation or control mechanism 3600 isshown. The control mechanism 3600 can be used to open and close firstand second clasps or gripping members 3610, 3620 to grasp nativeleaflets for implantation of an implantable prosthetic device. Thecontrol mechanism 3600 includes a first gripper control member 3612 anda second gripper control member 3622. The first gripper control member3612 is configured to move the first gripping member 3610bi-directionally in the direction X, and the second gripper controlmember 3622 is configured to move the first gripping member 3620bi-directionally in the direction Z. Movement of the first grippingmember 3610 in the direction X adjusts the width W of a first opening3616 between the first gripping member 3610 and a first paddle 3614, andmovement of the second gripping member 3620 in the direction Z willadjust the width H of a second opening 3626 between the second grippingmember 3620 and a second paddle 3624.

In the illustrated embodiment, the gripper control members 3610, 3620include a push/pull link 3611, 3621, such as, for example, a catheter, aflexible rod, or a stiff wire and a coupler 3613, 3623. Each push/pulllink 3611, 3621 extends from a delivery device 3602 and is removablyattached to the corresponding gripping member 3612, 3622 by the couplers3613, 3623. The link 3611 is configured to be pushed and pulled in thedirection Y. Movement of the link 3611 in the direction Y causes thegripping member 3610 to move in the direction X. Similarly, the link3621 is configured to be pushed and pulled in the direction M, andmovement of the link 3621 in the direction M causes the gripping member3620 to move in the direction H.

Referring now to FIGS. 188 and 188A, an actuation or control mechanism3700 for use in implantable prosthetic devices, such as the devicesdescribed in the present application, is shown. The actuation mechanism3700 allows for pushing and pulling of portions of an implantabledevice, such as the clasps or gripping members described above. Themechanism 3700 includes first and second control members 3710, 3720 thatextend from a delivery device 3702. The delivery device 3702 may be anysuitable device, such as a sheath or catheter. The first and secondcontrol members 3710, 3720 include first and second sutures 3712, 3722and first and second flexible wires 3714, 3724. The first and secondflexible wires 3714, 3724 extend from the delivery device 3702 and eachinclude a loop 3716, 3726 for receiving the first and second sutures3712, 3722 and for engaging a clasp or gripping member. Each of thefirst and second sutures 3712, 3722 extends from the delivery device3702, through a one of the first and second loops 3716, 3726,respectively, and back into the delivery device 3702. In the exampleillustrated by FIG. 188, each suture 3712, 3722 extends through one ofthe loops 3716, 3726 once. In the example illustrated by FIG. 188, eachsuture 3712, 3722 extends through one of the loops 3716, 3726 twice. Insome embodiments, the first and second control members 3712, 3722 extendthrough separate delivery devices 3702. The sutures 3712, 3722 areremovably attached to moveable arms of exemplary barbed clasps describedabove. The first and second loops 3716, 3726 of the respective wires3714, 3724 are able to move along the corresponding sutures 3712, 3722such that the loops 3716, 3726 can engage the corresponding barbedclasps to engage the moveable arms. That is, the sutures 3712, 3722 areused to pull the moveable arms in an opening direction and the wires3714, 3724 are used to push the moveable arms in a closing direction.The wires 3714, 3724 can be made of, for example, steel alloy,nickel-titanium alloy, or any other metal or plastic material. Incertain embodiments, the wires 3714, 3724 can have a diameter betweenabout 0.10 mm and about 0.35 mm, between about 0.15 mm and about 0.30mm, and between about 0.20 mm and about 0.25 mm. While the wires 3714,3724 are shown as coming out of separate lumens than the sutures 3712,3722, in another embodiment, the wires 3714, 3724 can share a lumen witha suture.

In the examples of FIGS. 188 and 188A, the wires 3714, 3724 can bereplaced with a rigid or semi-rigid tube or pushable coil. The tube orpushable coil can share a lumen with a suture loop, the suture loop canbe disposed inside the tube or pushable coil. The tube or pushable coilcan be advanced over one side or both sides of each suture loop to push.The tube, pushable coil, or wire can be retracted as necessary into thecatheter when not needed.

Referring now to FIG. 189, another exemplary embodiment of an actuationor control mechanism 3800 includes a first catheter 3811, a secondcatheter 3821, and single line 3830, such as a wire or suture. The firstcatheter 3811 and line 3830 are configured to move a first grippingmember 3810 in the direction X, and the second catheter 3821 and line3830 configured to move a second gripping member 3820 in the directionZ. Movement of the gripping member 3810 in the direction X will adjustthe width W of a first opening 3816 between the first gripping member3810 and a first paddle 3814, and movement of the second gripping member3820 in the direction Z will adjust the width H of a second opening 3826between the second gripping member 3820 and a second paddle 3824. Theline 3830 extends from a delivery device 3802 through the catheters3811, 3821 and is threaded through openings in both gripping member3810, 3820. Each catheter 3811, 3821 is configured to engage and movethe corresponding gripping member 3810, 3820. In particular, the firstcatheter 3811 is configured to be pushed in the direction Y while theline 3830 is payed out of the second catheter 3821 or tension in theline 3830 is reduced. The first catheter 3811 is configured to be pulledin the direction Y while the line 3830 is pulled into the first catheter3811 or tension in the line is increased. Movement of the first catheter3811 in the direction Y causes the first catheter 3811 to move the firstgripping member 3810 in the direction X. Similarly, the second catheter3821 is configured to be pushed in the direction M while the line 3830is payed out of the first catheter 3811 or tension in the line 3830 isreduced. The second catheter 3821 is configured to be pulled in thedirection M while the line 3830 is pulled into the second catheter 3821or tension in the line 3830 is increased. Movement of the secondcatheter 3821 in the direction M causes the second catheter 3821 to movethe second gripping member 3820 in the direction H. In an alternativeembodiment, the control mechanism 3800 described above with reference toFIG. 189 can include a first flexible wire with a loop (e.g., theflexible wire 3714 with the loop 3716 shown in FIG. 188) and a secondflexible wire with a loop (e.g., the flexible wire 3724 with the loop3726 shown in FIG. 188), and the single line 3830 extends through theloop 3716, 3726 of each of the wires 3830.

Referring to FIG. 190, another exemplary embodiment of an actuation orcontrol mechanism 3900 includes a single line 3930, such as a suture orwire, that is removably attached to first and second clasps or grippingmembers 3910, 3920 and removably fixed between a placement shaft 3904and a device shaft 3906 of an implantable device. The shafts 3904, 3906are similar to the shafts 3510, 3520, described in more detail above.The single line 3930 is connected at a connection 3908 between theshafts 3904, 3906, such that the single line 3930 can separately controlthe gripping members 3910, 3920. That is, movement of a first portion3832 of the line 3830 in a direction Y will adjust a width W between thefirst gripping member 3910 and a first paddle 3914, but will not adjusta width H between the second gripping member 3920 and a second paddle3924. Similarly, movement of a second portion 3934 of the line 3930 in adirection M will adjust a width H between the second gripping member3920 and a second paddle 3924, but will not adjust the width W betweenthe first gripping member 3910 and the first paddle 3914. After thevalve repair device is in a closed position and secured to the nativevalve tissue, the placement shaft 3904 is detached from the device shaft3906. Decoupling the shafts 3904, 3906 releases the line 3930 from theconnection 3908. The line 3930 can then be retracted into the catheter3902 to release the gripping members 3910, 3920 by pulling one end ofthe line 3930 into the catheter 3902. Pulling one end of the line 3930into the catheter 3902 pulls the other end of the line 3930 through thegripping members 3910, 3920 and then into the catheter 3902. Any of thelines described herein can be retracted in this manner.

While various inventive aspects, concepts and features of thedisclosures may be described and illustrated herein as embodied incombination in the exemplary embodiments, these various aspects,concepts, and features may be used in many alternative embodiments,either individually or in various combinations and sub-combinationsthereof. Unless expressly excluded herein all such combinations andsub-combinations are intended to be within the scope of the presentapplication. Still further, while various alternative embodiments as tothe various aspects, concepts, and features of the disclosures—such asalternative materials, structures, configurations, methods, devices, andcomponents, alternatives as to form, fit, and function, and so on—may bedescribed herein, such descriptions are not intended to be a complete orexhaustive list of available alternative embodiments, whether presentlyknown or later developed. Those skilled in the art may readily adopt oneor more of the inventive aspects, concepts, or features into additionalembodiments and uses within the scope of the present application even ifsuch embodiments are not expressly disclosed herein.

Additionally, even though some features, concepts, or aspects of thedisclosures may be described herein as being a preferred arrangement ormethod, such description is not intended to suggest that such feature isrequired or necessary unless expressly so stated. Still further,exemplary or representative values and ranges may be included to assistin understanding the present application, however, such values andranges are not to be construed in a limiting sense and are intended tobe critical values or ranges only if so expressly stated.

Moreover, while various aspects, features and concepts may be expresslyidentified herein as being inventive or forming part of a disclosure,such identification is not intended to be exclusive, but rather theremay be inventive aspects, concepts, and features that are fullydescribed herein without being expressly identified as such or as partof a specific disclosure, the disclosures instead being set forth in theappended claims. Descriptions of exemplary methods or processes are notlimited to inclusion of all steps as being required in all cases, nor isthe order that the steps are presented to be construed as required ornecessary unless expressly so stated. The words used in the claims havetheir full ordinary meanings and are not limited in any way by thedescription of the embodiments in the specification.

1. A valve repair device for repairing a native valve of a patient, thevalve repair device comprising: a paddle frame; an inner paddle; and anouter paddle connected to the inner paddle; wherein the inner and outerpaddles are connected to the paddle frame at a connection between theinner paddle and the outer paddle; and wherein a connection portion ofthe inner paddle is moveable away from a connection portion of the outerpaddle to open the inner and outer paddles.
 2. The valve repair deviceof claim 1 wherein pulling the connection portion of the outer paddleand a connection portion of the paddle frame away from the connectionportion of the inner paddle flexes the paddle frame outward to open theinner and outer paddles.
 3. The valve repair device of claim 1 whereinthe inner paddle is connected to the outer paddle by a flexible joint.4. The valve repair device of claim 3 wherein the paddle frame isconnected to the flexible joint.
 5. The valve repair device of claim 1wherein the inner paddle and the outer paddle are integrally formed. 6.The valve repair device of claim 1 wherein the inner paddle and theouter paddle are made from a flexible mesh material.
 7. The valve repairdevice of claim 6 wherein the inner paddle and the outer paddle are madefrom a flexible mesh material.
 8. The valve repair device of claim 1wherein the paddle frame has a round three-dimensional shape.
 9. Thevalve repair device of claim 1 wherein the paddle frame has a width thatis wider than the width of the inner and outer paddles.
 10. A valverepair device for repairing a native valve of a patient, the valverepair device comprising: a coaption element; a cap; a paddle frameconnected to the cap; an inner paddle connected to the coaption element;and an outer paddle connected to the cap and the inner paddle, such thatthe inner and outer paddles are disposed over the paddle frame; whereinthe cap is moveable away from the coaption element to open in the innerand outer paddles.
 11. The valve repair device of claim 10 whereinmovement of the cap away from the coaption element pulls the connectionportion of the outer paddle and the connection portion of the paddleframe away from the coaption element.
 12. The valve repair device ofclaim 11 wherein pulling the connection portion of the outer paddle andthe connection portion of the paddle frame away from the coaptionelement flexes the paddle frame away from the coaption element to openthe inner and outer paddles.
 13. The valve repair device of claim 10wherein the inner paddle is connected to the outer paddle by a flexiblejoint.
 14. The valve repair device of claim 13 wherein the paddle frameis connected to the flexible joint.
 15. The valve repair device of claim10 wherein the inner paddle and the outer paddle are integrally formed.16. The valve repair device of claim 10 wherein the inner paddle and theouter paddle are made from a flexible mesh material.
 17. The valverepair device of claim 16 wherein the inner paddle and the outer paddleare made from a flexible mesh material.
 18. The valve repair device ofclaim 10 wherein the inner paddle, the outer paddle, and the coaptionelement are integrally formed.
 19. The valve repair device of claim 10wherein the inner paddle, the outer paddle and the coaption element aremade from a flexible mesh material.
 20. The valve repair device of claim10 wherein the paddle frame has a round three-dimensional shape.
 21. Thevalve repair device of claim 10 wherein the paddle frame has a widththat is wider than the width of the inner and outer paddles.